BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI 6

    MDR report key: 415789 · Received September 5, 2002

    Report

    Report Number
    1823260-2002-00296
    Event Type
    Malfunction
    Date Received
    September 5, 2002
    Date of Event
    August 23, 2002
    Report Date
    August 26, 2002
    Manufacturer
    AVL GMBH
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SAMPLES WERE RUN ON THE SUSPECT ANALYZER FOR POTASSIUM AND WERE PATIENT #1 14.8 MEQ/L, REPEATED ON DIFFERENT ANALYZER AND 4.0 MEQ/L. PATIENT #2 9.9 MEQ/L, REPEATED ON DIFFERENT ANALYZER AND 4.9 MEQ/L. PATIENT #3 15.4 MEQ/L, REPEATED ON DIFFERENT ANALYZER AND 4.3 MEQ/L. PATIENT #4 12.8 MEQ/L, REPEATED ON DIFFERNT ANALYZER AND 3.5 MEQ/L. PATIENT #5 13.7 MEQ/L, REPEATED ON DIFFERENT ANALYZER AND 4.4 MEQ/L. PATIENT #6 14.7 MEQ/L, REPEATED ON DIFFERENT ANALYZER AND 3.7 MEQ/L. NO INFORMATION ON PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI 6 BLOOD GAS ANALYZER JJC AVL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *