BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA FLASH GBM REAGENTS

    MDR report key: 21389272 · Received February 14, 2025

    Report

    Report Number
    2026994-2025-00001
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    December 11, 2024
    Report Date
    February 14, 2025
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    JIX
    PMA / PMN Number
    K112545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED. NO HARM TO THE PATIENT WAS REPORTED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL BEFORE TREATMENT WAS INITIATED. INSTRUMENT DATA, TESTING DATA, AND PATIENT SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER AND WILL BE ANALYZED AS PART OF THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A PATIENT WITH GROSS HEMATURIA WAS TESTED USING THE QUANTA FLASH GBM LOT 244340 AND HIGH POSITIVE RESULTS WERE REPORTED ON INITIAL AND REPEAT TESTING. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE POSITIVE RESULTS WITH A PLAN TO PROCEED WITH PLASMAPHERESIS AND IMMUNOSUPPRESSIVE THERAPY. BEFORE THE TREATMENT WAS INITIATED, RETESTING WAS PERFORMED USING AN ALTERNATIVE METHOD (TYPE AND MANUFACTURER NOT REPORTED) AND THE GBM RESULT WAS NEGATIVE. THE PATIENT WAS SENT HOME WITHOUT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490335 QUANTA FLASH GBM REAGENTS CALIBRATOR, MULTI-ANALYTE MIXTURE JIX INOVA DIAGNOSTICS, INC. 244340

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization