BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 17823558 · Received September 27, 2023

    Report

    Report Number
    2243471-2023-03116
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE FLU A THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. 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 THE UNITED KINGDOM ALLEGED A DISCREPANT RESULT FOR A SINGLE PATIENT WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR THE SARS-COV-2 TARGET AND NEGATIVE RESULTS FOR THE INFLUENZA A AND INFLUENZA B TARGETS. THE SAME SAMPLE WAS RETESTED TWICE ON THE COBAS LIAT ANALYZER AND GENERATED NEGATIVE RESULTS FOR ALL TARGETS. A RECOLLECTED SAMPLE WAS TESTED ON A COMPETITOR ASSAY (GENEXPERT) AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2. 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
    984693 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 21107Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown