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FIELD CORRECTIVE ACTION LISTING FOR MARCH AND APRIL 2023
The list below contains Medical Device’s Field Corrective Action for the month of March and April 2023. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
(a) The return of the medical device to the establishment;
(b) Modification of the medical device;
(c) Exchange of the medical device;
(d) Destruction of medical device; or
(e) Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
15 March 2023 |
Access Immunoassay Systems Management Plan Urgent Field Safety Notice FA-23006 |
THYROID FUNCTION MARKERS |
MDA/FCA/P0287-60902259-2023 |
IVDB7247723-115154 |
Beckman Coulter has determined that Access Free T3 reagent lot 233968 was manufactured with a lower concentration of blocking reagent than required |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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4 April 2023 |
BECKMAN COULTER ELECTROLYTE REAGENTS |
MDA/FCA/P0316-45827197-2023 |
IVDB2268977017 |
Customer complaints were received in relation to multiple Bicarbonate reagent lots associated with CO2 calibration failures, high Quality Control Recoveries and/or false high patient results for CO2. This calibration failure is due to the premature drop off in calibration ODs observed for the complaint lots. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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6 April 2023 |
IQ200 SERIES URINE MICROSCOPY SYSTEM (INTERNATIONAL) |
MDA/FCA/P0317-62434837-2023 |
IVDB7671720-40408 |
On 22-Mar-29 Beckman Coulter made the decision to conduct a field action on iQ 200 Series, DxU 850m Iris and DxU 840m Iris instruments with installed configurations of PC7 Win 10 (PN C50890) Software Version 8.1and PC8 Win 10 (PN: C64316) Software Version 8.5, 8.5.1 and 8.6. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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26 April 2023 |
INSTRUMENT AND ACCESSORIES |
MDA/FCA/P0320-36161688-2023 |
IVDA19892104418 |
An issue that could be observed when performing ABO grouping tests for patients and/or donors on the IH-500 instrument. In case of absence of red blood cells (RBC) sample into the Anti-A well or Anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of Empty “E” as expected. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BIOMARKETING SERVICES (M) SDN BHD |
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31 March 2023 |
LYPHOCHEK COAGULATION CONTROL |
MDA/FCA/P0314-94480331-2023 |
IVDC56674137718 |
Bio-Rad have received intermittent complaints about flakes/clots in Lyphochek Coagulation Control. This product is prepared from non-defibrinated plasma; sporadic flakes/clots can form when the reconstituted product is frozen. |
ADELINE NG POOI KUAN GROUP CORPORATE COMPLIANCE SENIOR MANAGER CHEMOPHARM SDN BHD |
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30 March 2023 |
LIAISON® ALDOSTERONE |
MDA/FCA/P0304-27238994-2023 |
IVDB7132520-40385 |
DiaSorin aware that the affected lots may produce a positive shift in patient results and additionally invalid calibrations due to a failing Geometric Curve Check (GCC) may occur. |
ZAIDI BIN JANTAN REGULATORY AFFAIR AND QUALITY ASSURANCE EXECUTIVE DIAGNOSTICARE SDN BHD |
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13 March 2023 |
Infinity Central Station drops peaks on narrow waveforms causing M300 to fail |
DRAEGER MONITORING SYSTEM INFINITY CENTRAL STATION WITH M300 |
MDA/FCA/P0284-63797383-2023 |
GC71803874318 |
During our global market surveillance activities, we have become aware of cases in which the software on the Infinity Centralstation drops peaks on narrow waveforms causing the Infinity® M300 to fail clauses 201.12.1.101 and 201.12.1.101.8 within IEC 60601-2-27 Frequency and Impulse Response requirements. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
|
27 March 2023 |
FABIUS FAMILY |
MDA/FCA/P0307-58640509-2023 |
GC52775717518 |
During the course of our global market surveillance activities, we have become aware of cases in which glued connections of the breathing circuits loosened either before or during the ventilation process resulting in partial or complete detachment of components such as watertrap, y-piece or hose connector. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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27 March 2023 |
BREATHING CIRCUITS LDP1 VENTSTAR |
MDA/FCA/P0310-83428686-2023 |
GB9683320-50238 |
During the course of our global market surveillance activities, we have become aware of cases in which glued connections of the breathing circuits loosened either before or during the ventilation process resulting in partial or complete detachment of components such as watertrap, y-piece or hose connector. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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7 April 2023 |
Amicus MNC Apheresis Kit and Amicus Exchange Kit Therapeutics (ECMD202228) |
AMICUS SEPARATOR |
MDA/FCA/P0280-24850958-2023 |
GC61175798418 |
Based on routine post-market surveillance Fresenius Kabi has identified the potential for certain lots of Amicus MNC and Exchange kits to have leaking centrifuge packs during a procedure on the Amicus System using therapeutic protocols only. |
FOO AI LIN HEAD, SCIENTIFIC AND REGULATORY AFFAIRS FRESENIUS KABI MALAYSIA SDN BHD |
|
7 April 2023 |
MAQUET SERVO-AIR VENTILATION SYSTEM |
MDA/FCA/P0088-38247753-2022 |
GC66783764118 |
During new environmental tests, which includes the possibility that the user steps on the wheelbase, the earlier passed test results for Servo-air regarding the standard for vertical forces (IEC 60601-1 §9.4.2.3 b) could not be reproduced when testing an equivalent product. |
HUDA TAJUDDIN REGULATORY SPECIALIST IDS MEDICAL SYSTEMS (M) SDN BHD |
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10 March 2023 |
MONACO RTP SYSTEM SOFTWARE |
MDA/FCA/P0276-19613892-2023 |
GC7741121-73636 |
A sequence of steps performed by the user, consisting of an initial optimization, expansion of a structure or the creation of a new margin structure outside of the external contour and without forced density, change of the optimization criteria, and continuation of the optimization, may result in apertures that deliver doses on an incorrectly shifted position of the target — a geometrical miss. |
BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS |
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3 April 2023 |
AIMC 23-03 Atellica IM Folate – Improper Calibration for Serum Samples. |
ATELLICA IM FOLATE (FOL) |
MDA/FCA/P0195-99198869-2023 |
IVDB12482267618 |
Siemens’s investigation found the complainants had received the Atellica IM Folate kit lots ending in 337 and higher or ADVIA Centaur Folate kit lots ending in 336 and higher and were using a whole blood calibration. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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20 March 2023 |
COMBIDIAGNOST R90 |
MDA/FCA/P0294-46552284-2023 |
GC25585319317 |
If the CombiDiagnost R90 system experiences an overvoltage / power surge it can cause a short circuit condition within the Main-cabinet (M-Cabinet). The M-Cabinet is physically separated, but in or near the vicinity of the imaging suite. Philips has identified that the overvoltage impacts the Electromagnetic Interference (EMI) filter board which affects the System Power Distribution Unit (SPDU) contained within the M-Cabinet. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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20 March 2023 |
PROXIDIAGNOST N90 |
MDA/FCA/P0296-86320393-2023 |
GC625521251919 |
Issue 1: Component damage due to short circuit (CombiDiagnost R90 and ProxiDiagnost N90) Issue 2: Table stop due to a broken tabletop cable (ProxiDiagnost N90 only): On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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20 March 2023 |
TRILOGY EV300 |
MDA/FCA/P0298-31834091-2023 |
GC5498920-50666 |
Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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20 March 2023 |
TRILOGY EVO |
MDA/FCA/P0299-18256939-2023 |
GC2627520-39891 |
Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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20 March 2023 |
AZURION 3 |
MDA/FCA/P0300-53555292-2023 |
GC99381544218 |
When the full disk capacity is reached, X-Ray functionality will cease to be available without an advance warning to the user. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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|
20 March 2023 |
AZURION BIPLANE |
MDA/FCA/P0302-83662015-2023 |
GC59959884718 |
Philips has identified a potential safety issue where the Philips Azurion system may unexpectedly lose X-ray functionality. Due to a software issue, a mechanism that is present in the system to manage the number and size of Log Trace Files does not function properly. Without this mechanism, the Log Trace Files created by the system (e.g., at start, during use) may occupy the full disk capacity of the Philips Azurion system. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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20 March 2023 |
2023-PD-CTAMI-005 Spectral CT 7500 Multi-Function Foot Switch Unload Pedal Foot Entrapment |
SPECTRAL CT |
MDA/FCA/P0303-19969966-2023 |
GC6307722-96412 |
Philips has identified that pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator’s foot. Three-foot pedals are located on the Multi-Function Foot Switch which can be operated from either side of the patient table. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
6 April 2023 |
2023-CC-SRC-003 - Trilogy Evo Environmental Contamination of Device Sensor |
TRILOGY EVO |
MDA/FCA/P0323-27854479-2023 |
GC2627520-39891 |
Philips Respironics has detected environmental debris (e.g., external dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental debris can lead to buildup of particulate on the internal flow sensor within the device. This may cause the device to inaccurately deliver pressure, volume, or flow. Routinely rinsing the air-inlet foam filter, as specified in the section titled Rinsing the Air-Inlet Foam Filter of the Instructions for Use, and using a particulate filter prevents accumulation of environmental debris that can cause a device malfunction. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
6 April 2023 |
Urgent Field Safety Notice - QIAstat-Dx® Gastrointestinal Panel REF 691411 (Lots 220218 and 220224) |
QIASTAT-DX® GASTROINTESTINAL PANEL |
MDA/FCA/P0318-81093485-2023 |
IVDC2113619-30804 |
This Urgent Field Safety Notice is to inform you that QIAGEN has discovered a malfunction on cartridges of LOTS 220218 and 220224 of the QIAstat-Dx Gastrointestinal Panel, REF 691411. |
DEBRA ANNE ANTHONY PETER REGULATORY AFFAIRS MANAGER, APAC QIAGEN BIOTECHNOLOGY MALAYSIA SDN BHD |
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4 April 2023 |
CARDIOVIT CS-104 |
MDA/FCA/P0271-89827713-2023 |
GB7213620-39610 |
Manufacturer SCHILLER AG received question from a Swiss distribution partner about the installation and service handbook as it is only required to perform the electrical safety test according to the medical electrical (ME) equipment protection class II. As there are accessible parts of metal, the ME equipment should be tested according to PROTECTION CLASS I as required in IEC 60601-1. |
LIM THIAM HONG DIRECTOR SCHILLER ASIA PACIFIC SDN. BHD. |
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20 April 2023 |
Voluntary Product Exchange for Disposable Syringe 10cc Luer Slip |
STERILE DISPOSABLE SYRINGES LUER SLIP |
MDA/FCA/P0295-43922871-2023 |
GA68398348917 |
Initially Selia-Tek Indusrtiries Sdn. Bhd received a few complaints from customer on the affected lot: 21121310S50 & 22010310S50. Selia-Tek Industries Sdn Bhd has requested for conditional acceptance for the affected lot and Pharmaniaga Logistic Sdn. Bhd has forwarded the request to the Government. However, the Government has rejected the request and Pharmaniaga Logistic Sdn. Bhd has advise us to perform voluntarily product exchange. |
MOHD KHAIRI BIN MAT ISA GENERAL MANAGER SELIA-TEK INDUSTRIES SDN BHD |
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23 March 2023 |
AX061/22/S (FSCA), AX065/22/S (FSN) Artis one hybrid cable replacement |
ARTIS ONE |
MDA/FCA/P0305-52861417-2023 |
GC26661314317 |
Due to a potential malfunction, the examination room monitor connected with the hybrid cable may have a display issue. The issue occurs sporadically and might occur during procedure. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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20 April 2023 |
AIMC 23-07 ADVIA Centaur Systems Urine Cortisol Negative Bias |
ADVIA CENTAUR® CORTISOL (COR) |
MDA/FCA/P0312-29842821-2023 |
IVDB2211648817 |
The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide instructions on actions that your laboratory must take. Siemens Healthcare Diagnostics Inc. has confirmed customer observations of a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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3 April 2023 |
EPOC BLOOD ANALYSIS SYSTEM |
MDA/FCA/P0315-12840160-2023 |
IVDC7557621-75750 |
Siemens Healthcare Diagnostics Inc. has confirmed that, in rare instances, the epoc reader may incorrectly decode the barcode of a BGEM Test Card lot number to a different BGEM lot number. For example, BGEM Test Card with lot number A is inserted into the epoc Reader and the barcode is then incorrectly decoded as BGEM Test Card lot number B. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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7 March 2023 |
MEDICAL VENTILATOR |
MDA/FCA/P0274-63163555-2023 |
GC25545945118 |
Possibility to have and experience below malfunction: Malfunction 1: Safety ventilation can be triggered by switching to an adaptive mode Malfunction 2: The display can be restarted by changing the Target Shifts setting (only in INTELLIiVENT-ASV) |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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29 March 2023 |
REVOHEM_PLATELET AGGREGATION TEST |
MDA/FCA/P0308-82377022-2023 |
IVDB14960290718 |
Following a complaint on Revohem™ Arachidonic acid, reference BV413997, lot FB0459, and internal investigations, it was confirmed that some Revohem™ Arachidonic acid kits of lot FB0459 were packaged in a pre-printed box of Revohem™ ADP. |
JANICE HO SU YI SENIOR REGULATORY AFFAIRS SPECIALIST SYSMEX (MALAYSIA) SDN. BHD. |
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6 April 2023 |
REVOHEM_PLATELET AGGREGATION TEST |
MDA/FCA/P0309-61588914-2023 |
IVDB14960290718 |
Following a complaint on Revohem™ ADP, reference AP200422, lot FA1958, we confirm that some Revohem™ ADP kits of lot FA1958 were packaged in a pre-printed box of Revohem™ Arachidonic acid. |
JANICE HO SU YI SENIOR REGULATORY AFFAIRS SPECIALIST SYSMEX (MALAYSIA) SDN. BHD. |
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16 March 2023 |
IMPORTANT PRODUCT CORRECTION NOTIFICATION VITROS® Chemistry Products ALTV Slides Do Not Meet Ascorbic Acid Specificity Concentration in Instructions For Use
|
VITROS CHEMISTRY PRODUCTS ALANINE AMINOTRANSFERASE (ALTV) SLIDES |
MDA/FCA/P0289-52909383-2023 |
IVDB99769281318 |
From internal testing, Ortho became aware that coatings 3230, 3233, 3237, 3242, and 3243 do not meet the ascorbic acid specificity concentration of 100 mg/dL. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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16 March 2023 |
Issue 2: Leak in the High Pressure Helium Regulator Issue 3: Helium Leak at the Pump Console Quick Disconnect Fitting
|
MAQUET CARDIOSAVE IABP |
MDA/FCA/P0291-90788681-2023 |
GC51897893518 |
Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to four issues that could affect IABP performance: Issue 1: Unexpected Shutdown due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. Issue 2: Leak in the High Pressure Helium Regulator Issue 3: Helium Leak at the Pump Console Quick Disconnect Fitting |
TAN AIK CHUNG DIRECTOR VITALTECH SERVICES SDN BHD |
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20 April 2023 |
Missing Integrated Reaction Unit (IRU) Elevator panel on Alinity M System. |
ALINITY M SYSTEM |
MDA/FCA/P0332-97134960-2023 |
IVDB7120020-41682 |
Abbott has identified instruments installed without the shield panel at the Integrated Reaction Unit (IRU) elevators. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
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26 April 2023 |
EP-TRACER 38 and EP-TRACER 102 Internal reference number 2201 Rework of devices in the field is needed, clinical use can be continued.
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ELECTROPHYSIOLOGICAL MEASUREMENT SYSTEM (EP-TRACER) |
MDA/FCA/P0127-12757110-2022 |
GC72889950218 |
The EP-TRACER requires certain creepage distances and air clearances. During an internal investigation of a device that had failed under a test-specific high voltage condition of a third party - obviously without a patient present - we identified a position at which the mentioned distances were not met. |
LIM LEEI LIH MEDISCAPE SDN BHD |
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6 April 2023 |
2023-CC-SRC-003 - Trilogy EV300 Environmental Contamination of Device Sensor |
TRILOGY EV300 |
MDA/FCA/P0324-17342678-2023 |
GC5498920-50666 |
Philips Respironics has detected environmental debris (e.g, external dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental debris can lead to build up of particulate on the internal flow sensor within the device. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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7 April 2023 |
QIAstat-Dx Meningitis/Encephalitis Panel Lot 220193 / 220199 |
QIASTAT-DX® MENINGITIS/ENCEPHALITIS (ME) PANEL |
MDA/FCA/P0326-22447105-2023 |
IVDC5445422-101589 |
Several complaints received for lots listed related with reliability failures caused by Internal Control (IC) inhibition (error code x14023). This drives to abortion of run and do not deliver any result at all to user. |
DEBRA ANNE ANTHONY PETER REGULATORY AFFAIRS MANAGER, APAC QIAGEN BIOTECHNOLOGY MALAYSIA SDN BHD |
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10 April 2023 |
QUIKLYTE INTEGRATED MULTISENSOR NA+ /K+ /CL- |
MDA/FCA/P0102-20234435-2022 |
IVDB97817211918 |
Siemens Healthineers has received reports of sodium calibration failures (Error code 384 - IMT failed to calibrate) with the Dimension QuikLYTE Integrated Multisensor lots listed in Table 1 due to a low sodium slope exceeding the acceptable slope limit. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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27 April 2023 |
ADVIA® CHEMISTRY SALICYLATE (SAL) |
MDA/FCA/P0327-84554757-2023 |
IVDB3549971517 |
Customers complaints from outside the United States (OUS) have reported that the ADVIA Chemistry Salicylate (SAL) and Atellica CH Salicylate (Sal) methods are failing to recover within the acceptable ranges for their proficiency surveys. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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27 April 2023 |
ATELLICA CH SALICYLATE (SAL) |
MDAFCAP0328-35250541-2023 |
IVDB53652140218 |
Customers complaints from outside the United States (OUS) have reported that the ADVIA Chemistry Salicylate (SAL) and Atellica CH Salicylate (Sal) methods are failing to recover within the acceptable ranges for their proficiency surveys. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
