BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 AND INFLUENZA A/B

    MDR report key: 17596018 · Received August 22, 2023

    Report

    Report Number
    2243471-2023-02726
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS SHOWN IN THE DATA PROVIDED, THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE FLU B TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. THIS WOULD EXPLAIN WHY WAVERING RESULTS WERE GENERATED WHEN THE SAMPLE WAS REPEATED. LOW VIRAL LOAD SPECIMENS THAT ARE NEAR THE ASSAY LOD MAY NOT GENERATE CONSISTENT RESULTS UPON REPEAT TESTING ACCORDING TO EXPECTED STATISTICAL VARIANCES IN DETECTION. THIS IS A SAMPLE SPECIFIC ISSUE AND THE REAGENT IS PERFORMING AS INTENDED.

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM (B)(6) ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS LIAT SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR INFLUENZA A (SARS-COV-2 NEGATIVE, INFLUENZA B NEGATIVE). THE SAME SAMPLE WAS RETESTED ON A DIFFERENT PLATFORM (GENEXPERT) WHICH YIELDED A NEGATIVE RESULT FOR INFLUENZA A. THE INITIAL POSITIVE RESULT WAS NOT REPORTED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE. PER FDA¿S EUA GUIDANCE, 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50491 COBAS® SARS-COV-2 AND INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 21114F

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female