BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® 4800 BRAF V600 MUTATION TEST

    MDR report key: 19392302 · Received May 24, 2024

    Report

    Report Number
    2243471-2024-01551
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    OWD
    PMA / PMN Number
    P110020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. BASED ON THE INFORMATION PROVIDED, THE DIFFERENCES BETWEEN THE TECHNOLOGIES LIKELY CONTRIBUTED TO THE OBSERVED DISCREPANCY.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS Z 480 INSTRUMENT WAS REQUESTED BUT NOT PROVIDED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS® 4800 BRAF V600 MUTATION TEST. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT WHEN TESTED WITH A LAB DEVELOPED TEST, A DIAGNOSTIC TEST CALLED MEBGEN RASKET B-KIT, MARKETED BY A COMPETITOR, MEDICAL AND BIOLOGICAL LABORATORIES INC. THE SAME SAMPLE WAS THEN TESTED ON THE COBAS Z480 INSTRUMENT GENERATING A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320452 COBAS® 4800 BRAF V600 MUTATION TEST SOMATIC GENE MUTATION DETECTION SYSTEM OWD ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J12854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown