BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B V2

    MDR report key: 20023190 · Received August 21, 2024

    Report

    Report Number
    2243471-2024-02403
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA230046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT ISSUE WAS IDENTIFIED. IT IS POSSIBLE THAT THE ALLEGED SAMPLES ARE AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY. LOD SAMPLES COULD WAIVER BETWEEN POSITIVE/NEGATIVE RESULTS WITH REPEAT TESTING. THE INTER-ASSAY DISCREPANCY COULD OCCUR DUE TO DIFFERENCES IN TECHNOLOGIES. A BATCH MDR IS BEING SUBMITTED TO REPRESENT ALL THE SAMPLES ON A GIVEN RUN. THIS WILL REPRESENT ONE EVENT ON A SINGLE DEVICE AS PER FDA GUIDANCE.

    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 ALLEGED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES WHILE USING THE COBAS SARS-COV-2 & INFLUENZA A/B V2 TEST FOR USE ON THE COBAS 58/68/8800 SYSTEMS. THE ALLEGED SAMPLES INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 AND PAN-SARBECOVIRUS (INFLUENZA A/B NEGATIVE). THE SAME SAMPLES WERE RETESTED ON THE COBAS 6800 INSTRUMENT AND GENERATED A NEGATIVE RESULT FOR SARS-COV-2 AND PAN-SARBECOVIRUS (INFLUENZA A/B NEGATIVE). THE SAME SAMPLES WERE REPEATED ON A COMPETITOR ASSAY (GRIFOLS PANTHER) WHICH YIELDED A NEGATIVE RESULT FOR SARS-COV-2. THE INITIAL POSITIVE RESULTS WERE NOT RELEASED. 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
    1014773 COBAS® SARS-COV-2 & INFLUENZA A/B V2 COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K29032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown