BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10825765 · Received November 11, 2020

    Report

    Report Number
    8020790-2020-00118
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    January 4, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY REGARDING A POTENTIAL FALSE POSITIVE RESULT WHILE TESTING A PATIENT SERUM SAMPLE USING THE VIDAS® SARS-COV-2 IGG (REFERENCE # 423834, LOT # 1008219760, EXPIRY DATE 23JUL2021). THE CUSTOMER REPORTED THAT THEY HAD TESTED THE SAME PATIENT'S SAMPLE USING AN ALTERNATIVE COMMERCIALLY AVAILABLE TECHNIQUE (CMIA ABBOTT) AND THAT THEY HAD OBTAINED A NEGATIVE RESULT. DURING THE INVESTIGATION, NO ANOMALIES WERE HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA, OR THE TESTS PERFORMED ON THE RETAIN KIT VIDAS® SARS COV-2 IGG LOT 1008219760 / 210723-0. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER'S ANOMALY DURING THE INVESTIGATION PERFORMED NEITHER ON THE INTERNAL QUALITY CONTROL MATERIAL, NOR ON NATURAL SAMPLES COLLECTED BEFORE THE PANDEMIC WHICH GAVE A NEGATIVE INTERPRETATION, WITH INDEXES FAR FROM THE POSITIVE THRESHOLD AS EXPECTED. WITHOUT THE CUSTOMER'S RETURN SAMPLE, THE LAB CANNOT PURSUE FURTHER INVESTIGATION AND CONFIRM WHICH RESULT SHOULD BE EXPECTED. THE PATIENT MAY HAVE BEEN ASYMPTOMATIC AND DEVELOPED ANTIBODIES WHICH WERE DETECTED BY VIDAS® SARS COV-2 IGG AND NOT BY ABBOTT METHOD. THE ANTIBODIES TYPE TARGETED BY THE METHOD COULD EXPLAIN THE DISCREPANCY OBSERVED (ANTIBODIES AGAINST RBD PROTEIN FOR VIDAS AND ANTIBODIES AGAINST NUCLEOCAPSID PROTEIN FOR ABBOTT). IT IS STATED IN VIDAS® SARS COV-2 IGM PACKAGE INSERT AT THE SECTION ¿LIMITATIONS OF THE METHOD¿ THE FOLLOWING: - 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. PER THE INVESTIGATION, VIDAS® SARS COV-2 IGG LOT 1008219760 / 210723-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A POTENTIAL FALSE POSITIVE RESULT WHILE TESTING A PATIENT SERUM SAMPLE USING THE VIDAS(R) SARS-COV-2 IGG (REFERENCE #: (B)(4), LOT # 1008219760, EXPIRY DATE 23JUL2021). THE TEST VALUE WAS 13.08. THE CUSTOMER REPORTED THAT THEY HAD TESTED THE SAME PATIENT'S SAMPLE USING AN ALTERNATIVE COMMERCIALLY AVAILABLE TECHNIQUE (CMIA ABBOTT), AND THAT THEY HAD OBTAINED A NEGATIVE RESULT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMERIEUX 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
    1291238 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008219760

    Patients

    Seq Age Sex Outcome Treatment
    1