BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA FLASH GBM REAGENTS

    MDR report key: 22189976 · Received June 11, 2025

    Report

    Report Number
    2026994-2025-00002
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 10, 2025
    Report Date
    June 11, 2025
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    MVJ
    PMA / PMN Number
    K112545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, NO QUALITY ISSUES HAVE BEEN IDENTIFIED WITH THE QUANTA FLASH GBM REAGENT LOT 254531. INSTRUMENT DATA, TESTING DATA, AND PATIENT SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER AND WILL BE ANALYZED AS PART OF THE COMPLAINT INVESTIGATION. ALL DATA REQUIRED FOR FORM 3500A HAS BEEN REQUESTED. FIELDS FOR WHICH DATA WAS NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A PATIENT WHO WAS EXPERIENCING RECURRENT VOMITING AND DIARRHEA INADVERTENTLY INGESTED AN UNKNOWN QUANTITY OF CAFFEINE TABLETS, WHICH WERE MISTAKEN FOR CHARCOAL TABLETS, ON (B)(6) 2025. THE PATIENT COLLAPSED AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. DURING HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH UNEXPLAINED ACUTE RENAL FAILURE, WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 5 ML/MIN AND A CREATINE KINASE (CK) LEVEL OF 16,264 U/L. A KIDNEY BIOPSY WAS PERFORMED WHICH SHOWED SIGNS OF ACUTE TUBULAR DAMAGE. QUANTA FLASH GBM TESTING WAS CONDUCTED AND LOW POSITIVE RESULTS WERE OBTAINED ON BOTH THE INITIAL AND REPEAT GBM TESTS. A DIAGNOSIS OF GOODPASTURE SYNDROME COULD NOT BE EXCLUDED; THEREFORE, ON (B)(6) 2025, THE PATIENT WAS TREATED WITH CORTICOSTEROIDS AND UNDERWENT PLASMA EXCHANGE. CONFIRMATORY GBM TESTING WAS PERFORMED USING A DIFFERENT ELISA METHOD (SPECIFIC ASSAY AND MANUFACTURER NOT REPORTED), WHICH YIELDED A NEGATIVE RESULT. WITHIN TWO DAYS FOLLOWING TREATMENT, A SIGNIFICANT IMPROVEMENT IN RENAL RETENTION VALUES WAS REPORTED, AND THE IMMUNOSUPPRESSIVE TREATMENT WAS DISCONTINUED. THE FINAL DIAGNOSIS WAS RHABDOMYLOSIS WITH ANTICIPATORY NAUSEA AND VOMITING (ANV) IN EXSICCOSIS, FOLLOWING SUSPECTED GASTROENTERITIS, WITH QUESTIONABLE INITIAL CEREBRAL SEIZURE AND POSTICTAL LYING TRAUMA. NO SERIOUS HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71086 QUANTA FLASH GBM REAGENTS QUANTA FLASH GBM REAGENTS MVJ INOVA DIAGNOSTICS, INC. 254531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other