BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIOMETER ABL77

    MDR report key: 375369 · Received February 1, 2002

    Report

    Report Number
    2027541-2002-00002
    Event Type
    Other
    Date Received
    February 1, 2002
    Date of Event
    January 8, 2002
    Report Date
    January 13, 2002
    Manufacturer
    SENDX MEDICAL, INC./A RADIOMETER CO.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCORRECT BARCODE ON CALIBRATION PACK FOR ABL77 MAY CAUSE INITIALIZATION AND CALIBRATION FAILURE. ANALYZER IS UNABLE TO PERFORM ITS ESSENTIAL FUNCTION AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOMETER ABL77 PH, BLOOD GAS & ELECTROLYTE ANALYZER CFR SENDX MEDICAL, INC./A RADIOMETER CO. ABL77 CALPACK 54686

    Patients

    Seq Age Sex Outcome Treatment
    1 *