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FIELD CORRECTIVE ACTION (FCA) LISTING FOR AUGUST 2022
The list below contains Medical Device’s Field Corrective Action for the month of August 2022. 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 –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- 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 |
|
4 August 2022 |
Alinity ci-series System Control Module (SCM) |
MDA/FCA/2022-P127 |
IVDA3247720-46201 |
Abbott has identified a potential performance issue found in the Alinity ci-series software versions 3.3.3 and lower. Abbott is releasing Alinity ci-series software version 3.4.0 to correct this issue |
Farah Syuhaidah binti Ahmad Jahiddin Regulatory Affairs & Quality Assurance Executive Abbott Laboratories (M) Sdn. Bhd. |
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10 August 2022 |
FCA Notification on Immunoassay Speciality Control Level 1, 2 and 3 - stability period is shortened from 1 day to 8 hours |
Randox Immunoassay Speciality Control Level 1, 2 and 3 |
MDA/FCA/2022-P128 |
IVD79016125118 |
Low risk as stability period is shortened from 1 day to 8 hours |
Mark Ong, Biorex Mannheim Malaysia Sdn Bhd |
|
12 Sept 2022 |
Field Corrective Action on BinaxNOW Nasopharyngeal Swab Pack |
BINAXNOW RSV CARD |
MDA/FCA/P0005-82380934-2022 |
IVDC21199341118 |
Missing the supplementary local label that Medical Device Authority (MDA) requires. The subject label contains the Name, Address and the COnntact Number of Authorised Representative and the MDA Registration Number. |
Law Ching Yee Regulatory Affairs & Compliance Manager Abbott Medical (Malaysia) Sdn. Bhd |
|
18 August 2022 |
Assurity & Endurity Laser Adhesion Preparation Field Safety Corrective Action (FA-Q322-CRM-1) |
ASSURITY & ASSURITY MRI PACEMAKERS |
MDA/FCA/P0028-14319524-2022 |
GD71875822118 |
Abbott is informing clinicians of the potential for device malfunction which may affect a specific subset of serial numbers of AssurityTM and EndurityTM pacemakers. |
Law Ching Yee Regulatory Affairs & Compliance Manager Abbott Medical (Malaysia) Sdn. Bhd. |
|
3 August 2022 |
FA09JUN2022 ARCHITECT Hemoglobin A1c (A1c) and Alinity c Hemoglobin A1c |
HEMOGLOBIN A1C |
MDA/FCA/PX0036-57022116-2022 |
IVDB24013273018 |
Internal data analysis found that for ARCHITECT HbA1c, LN 04P52-20, and Alinity c HbA1c, LN 08P4320 and 08P4377, when the Total Hemoglobin concentration is to be erratic when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low Total Hemoglobin values. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
3 August 2022 |
FA09JUN2022 ARCHITECT Hemoglobin A1c (A1c) and Alinity c Hemoglobin A1c |
ALINITY C HBA1C |
MDA/FCA/PX0038-15790437-2022 |
IVDB6127219-28113 |
Internal data analysis found that for ARCHITECT HbA1c, LN 04P52-20, and Alinity c HbA1c, LN 08P4320 and 08P4377, when the Total Hemoglobin concentration is <1250 μmol/L there is a potential for the reported %HbA1c to be erratic when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low Total Hemoglobin values. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
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8 August 2022 |
ICHEM VELOCITY URINE CHEMISTRY SYSTEM |
MDA/FCA/P0030-67757121-2022 |
IVDB33139176018 |
A strip lot number result for Nitrite was overestimated (high) and the result for Leukocyte Esterase was underestimated (low) on quality control (QC) samples with lot 7204612M. Customer retested QC, and QC passed during retest and customer ran patient samples. Erroneous patient results were generated. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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25 August 2022 |
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent |
IMMAGE RHEUMATOID-INFLAMMATORY DISEASE MARKERS |
MDA/FCA/P0067-37877392-2022 |
IVDB93928233618 |
Extremely high RF concentrations (> 6,000 IU/mL) in serum may result in an antigen excess condition producing a low RF value on the IMMAGE System. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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29 August 2022 |
Automatic samples approval issue with Phadia 200 instrument. |
PHADIA INSTRUMENTS |
MDA/FCA/P0061-39015744-2022 |
IVDA1670544317 |
An issue has been found when the Phadia 200 Software has the setting “Automatic approval by each available result” and the Curve Control (CC) for an EliA assay run is not OK. This combination can lead to samples being approved without an OK Curve Control for the assay run. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BIOMARKETING SERVICES (M) SDN BHD |
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24 August 2022 |
Bearing pin might come loose and Patient Seat of the Unit might
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DENTAL TREATMENT CHAIR TENEO |
MDA/FCA/P0065-92992143-2022 |
GB8397719-30974 |
A spot check investigation within the affected population the market, initiated after issue 8000573478 showed that there were 5 of 20 devices where this bearing pin has moved out of its original position. The movement of that bearing pin in one direction is uncritical, because of an internal stop plate. |
SITI SARA BINTI MOHAMED REGULATORY AFFAIRS MANAGER DENTSPLY SIRONA MALAYSIA SDN. BHD. |
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22 August 2022 |
NexSys® PCS (1.4.2 and earlier)- Interruption during "Smart Last Cycle" |
PCS®300 PLASMA COLLECTION SYSTEM (NEXSYS PCS™) |
MDA/FCA/P0010-18518824-2022 |
GC5412720-49541 |
This software defect, under certain conditions, can affect the calculation of estimated Red Blood Cell (RBC) Loss and the associated system flags, when a “Smart Last Cycle” is interrupted. |
CHENG CHIN YEE SENIOR REGULATORY AFFAIRS SPECIALIST HAEMONETICS MALAYSIA SDN. BHD. |
|
21 August 2022 |
FA1243 Phase III Pump Inner Bearing Demagnetization - Investigation Update |
HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD) |
MDA/FCA/P0024-87946717-2022 |
GD74345985518 |
Three (3) complaints (see below) have been identified where the magnets inside the center post of the HVAD pump corroded causing the pump impeller to rotate non-concentrically and contact the center post inside the pump. All 3 cases had high watt alarms which led to a pump exchange. |
LEE YOUN YOUN REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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17 August 2022 |
STEALTHSTATION S7 TREATMENT GUIDANCE SYSTEM (CRANIAL) |
MDA/FCA/P0055-73877537-2022 |
GD86373862018 |
If the user encounters the software anomaly where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, there is the potential to navigate the biopsy needle too shallow or deep to target. This issue can potentially lead to resection of normal brain tissue or eloquent anatomical regions of the brain. |
LEE YOUN YOUN REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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8 August 2022 |
BiPAP A30, BiPAP A40 and OmniLab Advanced+ Motor Stator Material Non-Conformance
|
BIPAP A40 VENTILATOR |
MDA/FCA/P0045-76195787-2022 |
GC65940156417 |
Philips Respironics determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. If the non-conforming plastic is present in the device motor, it could lead to off-gassing and structural failure causing the immediate and sudden failure of the device during use. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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12 August 2022 |
MEDICAL DEVICE - FIELD NOTIFICATION STERRAD 100NX STERILIZATION SYSTEM (Parts: 10104, 10104-002, 10104-003, 10104-004) STERRAD 100NX STERILIZATION SYSTEM WITH ALL CLEAR TECHNOLOGY (Parts: 10104-005, 10104-006, 10104-007, 10104-008)
|
ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0049-45627563-2022 |
GC15247682318 |
ASP has determined certain STERRAD 100NX Sterilization Systems may exceed the CISPR 11 Group 1, Class A radiated emissions limits as set forth in international electrotechnical standard, IEC 60601-1-2: Medical Electrical Equipment - Electromagnetic Compatibility - Requirements and Tests. |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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24 August 2022 |
IMMUNOGLOBULINS |
MDA/FCA/P0062-22213860-2022 |
IVDB52967131318 |
Siemens Healthcare Diagnostics Products GmbH has confirmed that the N Antiserum to Human IgG lots mentioned above are not meeting the current High-Dose Hook Effect expectation given in the Instructions for Use (IFU) for the urine and CSF sample material. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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15 July 2022 |
IMMUNOGLOBULINS (N LATEX FLC KAPPA AND N LATEX FLC LAMBDA) |
MDA/FCA/P0008-87189324-2022 |
IVDB6883521-63634 |
Siemens Healthcare Diagnostics Products GmbH has confirmed that customers may experience an increased rate (average flagging rate: 6%) of flagged FLC LAMBDA Quality Control (QC) and patient sample results when using this assay on the Atellica CH 930 Analyzer. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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5 August 2022 |
Providing MS hotfix, bug fixing and workflow improvement for software VA40A with service pack 2
|
SOMATOM GO.TOP |
MDA/FCA/P0040-47741375-2022 |
GC110591186618 |
CT017/22/S for P81/82 Providing MS hotfix, bug fixing and workflow improvement for software VA40A with service pack 2 |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
|
9 August 2022 |
SOMATOM GO.TOP |
MDA/FCA/P0047-52243946-2022 |
GC110591186618 |
Some technical issues have been identified in software version syngo CT VA30A SP4, and these issues may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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23 August 2022 |
ARTIS Q |
MDA/FCA/P0054-87246920-2022 |
GC98740520118 |
The Artis system is provided with a dedicated error detection mechanism. In rare cases of failure of this error detection mechanism it will not be possible to release X‐ray anymore until system shutdown |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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1 Sept 2022 |
MEDICAL VENTILATOR |
MDA/FCA/P0015-76118627-2022 |
GC25545945118 |
The defective contact results in a detected technical fault. The two sequences of events can be summarized as follows: 1. the status indicator board may become loose 2.water ingress may lead to oxidation 3.Loose contact is detected as technical faukt multiple times within a very short time 4.An overflow of flog entries of TE 246041 (taLLS_alarmLedError) force the ventilator into "Safety ventilation" or "Ambient state with Panel connection lost message displaye |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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1 Sept 2022 |
MEDICAL VENTILATOR |
MDA/FCA/P0068-40052483-2022 |
GC25545945118 |
Failure of the backlight on the screen (to 2-3 seconds) of the HAMILTON-C6 with potential cause of confusion of the proper application of the ventilator. Issue reported through customer complaint to Hamilton Medical AG and reported to Swissmedic. |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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22 August 2022 |
PRODUCT CORRECTION NOTIFICATION - Report Submitted per to 21 CFR 806 (Report Reference Number 3010939897-04/28/22-001-R)
|
QMS TACROLIMUS IMMUNOASSAY |
MDA/FCA/P0052-82522298-2022 |
IVDC72318308018 |
Microgenics Corporation has identified QMS® Tacrolimus Calibrator, catalog number 10015573, lot numbers 74267412, 74175462, 74085025, 73925326, 73767734 and 73712031 are recovering between 85 – 93% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS® Tacrolimus Immunoassay. |
EIK LEE FANG QUALITY SYSTEMS MANAGER DIAGNOSTIC SYSTEMS (M) SDN. BHD. |
