BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI 5

    MDR report key: 403167 · Received July 2, 2002

    Report

    Report Number
    1823260-2002-00208
    Event Type
    Injury
    Date Received
    July 2, 2002
    Date of Event
    June 10, 2002
    Report Date
    June 10, 2002
    Manufacturer
    AVL GMBH
    Product Code
    JJC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IS ALLEGING THAT THEY TESTED A PATIENT SPECIMEN AND RECEIVED AN ERRONEOUS RESULT FOR K (POTASSIUM). PATIENT UNDERWENT DIALYSIS DUE TO ERRONEOUS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI 5 MODULAR CRITICAL CARE ANALYZER JJC AVL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention