BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 21912221 · Received April 25, 2025

    Report

    Report Number
    2243471-2025-01283
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 5, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INDICATED NO PRODUCT ISSUE FOUND. THE OBSERVED DISCREPANCY IS MOST LIKELY DUE TO THE SAMPLE BEING A WEAK POSITIVE FOR THE TARGET THAT IS AT/NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY AND VARYING ASSAY SENSITIVITIES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450034 COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT SYSTEM MULTI-TARGET RESP SPECIMEN NAT INCL. SARS-COV-2 & OTHER MICROBIAL AGENTS QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 41104A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown