BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 15305834 · Received August 26, 2022

    Report

    Report Number
    2243471-2022-00741
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SAMPLE-SPECIFIC ISSUE AND THE REAGENT IS PERFORMING AS INTENDED. THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE SARS-COV-2 TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. VERY 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. A RESULT DISCREPANCY MAY BE EXPECTED BETWEEN ASSAYS DUE TO POTENTIAL DIFFERENCES IN THE TESTS¿ LIMITS OF DETECTION (LOD) AND INTENDED USE. IT IS TO BE NOTED THAT THE CUSTOMER IS TAKING SALIVA TESTS IN LONGSEE VIRAL TRANSPORT MEDIA, 3ML WHICH IS OFF-LABEL.

    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 HONG KONG ALLEGED DISCREPANT RESULTS FOR ONE PATIENT USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST ASSAY FOR USE ON THE COBAS LIAT SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 WHEN TESTED ON COBAS LIAT. THE SAME SAMPLE WAS REPEAT TESTED ON A COMPETITOR PLATFORM (GENEXPERT) AND GENERATED NEGATIVE RESULTS. THE NEGATIVE RESULTS WERE REPORTED. NO HARM IS ALLEGED PER FDA GUIDANCE FOR EUA, 1 MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200889 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 20207L

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female