BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRA 1000C

    MDR report key: 124207 · Received October 1, 1997

    Report

    Report Number
    2424022-1997-00002
    Event Type
    Injury
    Date Received
    October 1, 1997
    Date of Event
    September 16, 1997
    Report Date
    September 19, 1997
    Manufacturer
    MEDICAL LABORATORY AUTOMATION
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO UNDERSTAND WHAT AN NCD (NO CLOT DETECTED) MEANS ON CO'S INSTRUMENT. OPERATOR REPORTED RESULTS AS GREATER THAN 100 SECONDS WHEN IT WAS UNDER 7 SECONDS. PT WAS GIVEN FRESH FROZEN PLASMA WHICH RESULTED IN PULMONARY EDEMA. CUSTOMER WAS RUNNING REAGENTS IN THE WRONG PROTOCOL AND INTERPRETING THE RESULTS INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRA 1000C BLOOD COAGULATION ANALYZER GKP MEDICAL LABORATORY AUTOMATION ELECTRA 1000C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening