BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 20163342 · Received September 6, 2024

    Report

    Report Number
    2243471-2024-02591
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QOF
    PMA / PMN Number
    K223591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS® LIAT® ANALYZER IS (B)(6). THE AFFECTED RUN DATA COULD NOT PROVIDED FOR REVIEW AND ANALYSIS. THE REAGENT INVESTIGATION DID NOT IDENTIFY A SYSTEMIC PRODUCT PROBLEM. THE EXACT ROOT CAUSE OF THE ISSUE REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SARS-COV-2 RESULT FOR A PATIENT SAMPLE USING COBAS® SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 (NEGATIVE FOR INFLUENZA A/B). THE SAME SAMPLE WAS REPEATED ON A COMPETITOR ASSAY (GENEXPERT) AND WAS NEGATIVE. THE REPEAT RESULT WAS DEEMED CORRECT, AND THE PATIENT'S RESULT WAS REPORTED AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345484 COBAS® SARS-COV-2 & INFLUENZA A/B MULTI-TARGET RESP SPECIMEN NAT INCL. SARS-COV-2 & OTHER MICROBIAL AGENTS QOF ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 40311E

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male