BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 11565607 · Received March 24, 2021

    Report

    Report Number
    8020790-2021-00056
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING FALSE POSITIVE RESULTS FOR A PATIENT WHEN USING VIDAS® SARS-COV-2 IGM (9COM) 60T (REF. 423833, LOT 1008333260, EXPIRY DATE = 24 SEPT 2021) WITH THEIR VIDAS® 3. THE RESULTS WERE NEGATIVE WITH ANOTHER METHOD FOR TESTING SARS-COV-2 IGM. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: ACCORDING TO THE ANALYSIS OF THE QUALITY DATA, NO ANOMALY WAS FOUND DURING THE STAGES OF MANUFACTURE, CONTROL AND PACKAGING. ANALYSIS OF SIX (6) SERA WERE PERFORMED ON SEVEN (7) LOTS OF VIDAS SARS-COV-2 IGM REF. 423833 INCLUDING THE CLIENT BATCH#: 1008333260 / 210924-0. THE VIDAS SARS-COV-2 IGM BATCH #: 1008333260 / 210924-0 LOT WAS IN THE TREND OF THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED THE PATIENT SAMPLE RETURNED BY THE CUSTOMER ON THE RETAIN KIT OF VIDAS SARS-COV-2 IGM (BATCH #:1008366880 / 211014-0, OTHER LOT OF VIDAS SARS-COV-2 IGM) AS WELL AS THAN ON ANOTHER BATCH OF VIDAS SARS-COV-2 IGM WITH DIFFERENT RAW MATERIALS (BATCH #:1008141730 / 210611-0). 211014-0: 10.89 TV / POSITIVE, 210611-0: 9.73 TV / POSITIVE. THE POSITIVE RESULT OBTAINED BY THE CUSTOMER FOR THE PATIENT SAMPLE WAS CONFIRMED AT THE COMPLAINT LABORATORY ON VIDAS SARS-COV-2 IGM (BATCH #:1008366880 / 211014-0, OTHER LOT OF VIDAS SARS-COV-2 IGM) AS WELL AS ON (BATCH #:1008141730 / 210611-0) USED AS REFERENCE. A SPECIFICITY TESTING WAS PERFORMED BY THE COMPLAINTS LABORATORY ON 30 SERA / PLASMAS WITH THREE (3) BATCHES OF VIDAS SARS-COV-2 IGM, INCLUDING THE BATCH CITED BY THE CUSTOMER (1008333260 / 210924-0) WITH FIVE (5) PLASMAS AND FIVE (5) SERA TESTED ON EACH BATCH. THE SAMPLES COME FROM (B)(6) TAKEN BEFORE THE PANDEMIC. ALL THE RESULTS WERE NEGATIVE. REGARDING THE CUSTOMER BATCH (1008333260 / 210924-0), THE RESULTS RANGE FROM 0.06 TO 0.37 VT AND ARE ALL OF NEGATIVE INTERPRETATION. THREE (3) INTERNAL SERUM LIBRARY SAMPLES WERE TESTED ON THE RETAIN KIT OF THE CUSTOMER BATCH (1008333260 / 210924-0). THE RESULTS OBTAINED AT THE COMPLAINTS LABORATORY COMPLY WITH THEIR STANDARDS, AND ARE SIMILAR TO THE RESULTS OBTAINED DURING THE ACTIVITY CONTROL OF THE BATCH. THE VIDAS SARS-COV-2 IGM (BATCH #:1008333260 / 210924-0) HAS NOT CHANGED SINCE ITS RELEASE. THE PATIENT'S SAMPLE WAS SENT EXTERNALLY TO BE ASSAYED USING THE NOVA-LISA SARS-COV2 IGM METHOD. THE NOVA-LISA SARS-COV2 IGM RESULT WAS 4.16 NTU / NEGATIVE. THERE WAS A DISCREPANCY BETWEEN THE RESULT OBTAINED IN THE NOVA LISA METHOD AND THE RESULTS OBTAINED IN VIDAS 9COM. IN ADDITION, A TEST TO DETECT THE PRESENCE OR ABSENCE OF RHEUMATOID FACTORS WAS CARRIED OUT. THE RESULT IS OBTAINED POSITIVE WITH THE PRESENCE OF AGGLUTINATION AND THE TITER DETERMINED USING THE SEMI-QUANTITATIVE METHOD IS 168 IU / ML. DURING PRODUCT DEVELOPMENT, FR + SAMPLES WERE TESTED AND A FALSE POSITIVE RESULT WAS OBSERVED ON TWO OF THEM. THEREFORE, AN INTERFERENCE WITH THIS SAMPLE COULD BE LINKED TO RHEUMATOID FACTORS. PER THE PACKAGE INSERT THE FOLLOWING LIMITATIONS OF THE TEST ARE NOTED: INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS, THEREFORE, THE RESULTS OF THIS TEST SHOULD BE INTERPRETED TAKING INTO ACCOUNT THE CLINICAL CONTEXT AND POSSIBLY THE RESULTS OF OTHER TESTS. RESULTS OBTAINED USING SAMPLES FROM PATIENTS INFECTED WITH SARS-COV-2 SHOULD BE INTERPRETED WITH CAUTION. THIS TEST IS FOR QUALITATIVE DETECTION ONLY. THE ACTUAL TEST VALUE CANNOT BE USED TO DETERMINE THE AMOUNT OF SARS-COV-2 IGM ANTIBODY. THE MAGNITUDE OF THE RESULT MEASURED ABOVE THE CUTOFF IS NOT INDICATIVE OF THE TOTAL AMOUNT OF ANTIBODY PRESENT IN THE SAMPLE. THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING INFECTION WITH SARS-COV-2 VARIES WIDELY AND MAY GIVE DIFFERENT RESULTS WITH DOSAGES FROM DIFFERENT MANUFACTURERS. THE RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY. ACCORDING TO THE INVESTIGATIONS CARRIED OUT AT THE COMPLAINTS LABORATORY, VIDAS SARS-COV-2 IGM (BATCH # 1008333260 / 210924-0) STILL MEETS ITS SPECIFICATIONS.

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR A PATIENT WHEN USING VIDAS® SARS-COV-2 IGM (9COM) 60T (REF. 423833, LOT 1008333260, EXPIRY DATE = 24 SEPT 2021) WITH THEIR VIDAS® 3. THE RESULTS WERE NEGATIVE WITH ANOTHER METHOD FOR TESTING SARS-COV-2 IGM.THE CUSTOMER REPORTED THAT THE SAMPLES HAVE THE RHEUMATOID FACTOR, AND ARE SARS IGG NEGATIVE, WITHOUT SARS-COV-2 SYMPTOMS.(B)(6) 2021:SARS-COV-2-IGM POSITIVE (10.68)SARS-COV-2-IGG NEGATIVE (SUB FEBRILE TEMPERATURE)OTHER LABORATORY SARS-COV2-IGG/IGM-AK NEGATIVERF-IGM 61.1 IU/ML [<20.0] POSITIVERF-IGG 23.8 U/ML [<20.0], POSITIVERF-IGA NEGATIVE(B)(6) 2021:SARS-COV-2-IGM POSITIVE (8.96),SARS-COV-2-IGG NEGATIVE (SUB FEBRILE TEMPERATURE)(B)(6) 2021:SARS-COV-2-IGM POSITIVE (7.83),SARS-COV-2-IGG NEGATIVE (NO SYMPTOM)SERUM FROZENTHERE IS NO ADDITIONAL DATA AVAILABLE AT THE TIME OF THIS REPORT REGARDING THE CONCERNED PATIENT.THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT LED TO ANY IMPACT TO THE PATIENT STATE OF HEALTH.A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.NOTE: REFERENCE 423833 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423833-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423833.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459826 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008333260

    Patients

    Seq Age Sex Outcome Treatment
    1