BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11499891 · Received March 16, 2021

    Report

    Report Number
    8020790-2021-00029
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Report Date
    May 3, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN SPAIN REGARDING DISCREPANT RESULTS FOR SIX (6) DIFFERENT PATIENTS WHILE USING THE VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008430290 EXPIRY 11JUN2021). VIDAS® SARS-COV-2 IGG OBTAINED NEGATIVE RESULTS, WHILE THE SAMPLES WERE FOUND POSITIVE WITH OTHER METHODS (RAPID TEST AND ROCHE). THE CUSTOMER¿S SAMPLES WERE REQUESTED BUT WERE NOT AVAILABLE TO BE RETURNED FOR THE INVESTIGATION. THE ANALYSIS OF THE BATCH HISTORY RECORD OF VIDAS® SARS COV-2 IGG LOT 1008430290 / 210611-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES. AN ANALYSIS OF INTERNAL SAMPLES CONTROL CHARTS WAS PERFORMED ON FOUR (4) INTERNAL POSITIVES SERA (TARGETS BETWEEN 1,34 TV AND 2,23 TV) WITH SEVEN (7) BATCHES, INCLUDING THE LOT MENTIONED BY THE CUSTOMER. ALL VALUES ARE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOT IS WITHIN THE TREND OF THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (3 WITH POSITIVE TARGETS AND 1 NEGATIVE) ON THE RETAIN KIT OF VIDAS® SARS COV-2 IGG LOT 1008430290 / 210611-0. ALL SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH RELEASE. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER¿S VIDAS® SARS COV-2 IGG NEGATIVE RESULT WHEN TESTING INTERNAL POSITIVE SAMPLES ON THE BATCH 1008430290 / 210611-0. WITHOUT THE CUSTOMER¿S SAMPLE, BIOMÉRIEUX CANNOT PURSUE FURTHER THE INVESTIGATION AND EXPLAIN THE RESULT OBSERVED BY THIS CUSTOMER. THE PACKAGE INSERT OF VIDAS® SARS COV-2 IGG REF. 423834 MENTIONS THE FOLLOWING AT THE SECTION LIMITATIONS OF THE METHOD: RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING SARS-COV-2 INFECTION VARIES CONSIDERABLY AND MIGHT GIVE DIFFERENT RESULTS WITH ASSAYS FROM DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY. ACCORDING TO THE INVESTIGATION, VIDAS® SARS COV-2 IGG REF 423834 LOT 1008430290 / 210611-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT RESULTS FOR SIX (6) DIFFERENT PATIENTS WHILE USING THE VIDAS® SARS-COV-2 IGG (9COG) 60T (REF. 423834, LOT 1008430290 EXPIRY 11JUN2021). THE CUSTOMER PERFORMED A CALIBRATION TEST ON 11FEB2021 AND 15FEB2021 WITH PASSING RESULTS. VIDAS® SARS-COV-2 IGG RESULTS: NEGATIVE. ALTERNATE METHODS: ON AB. TOTALS IN COBAS 6000 FROM ROCHE, THE RESULTS WERE POSITIVES. VERIFICATION WITH AB. IGG AND IGM IN RAPID TEST , THE RESULTS WERE POSITIVE IGG. THE PATIENTS WERE TESTED BECAUSE IT WAS SUSPECTED THAT THEY WERE INFECTED WITH COVID-19 (MONITORING OF WORKERS IN COMPANY ANALYTICS AND/OR PRIVATE INDIVIDUALS WITH PAST COVID). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 423834 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S.-ONLY PRODUCT REFERENCE, 423834-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423834.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395575 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008430290

    Patients

    Seq Age Sex Outcome Treatment
    1