BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER

    MDR report key: 1810764 · Received August 16, 2010

    Report

    Report Number
    MW5017130
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LABORATORY EXPERIENCED AN INSTRUMENT FAILURE RESULTING IN FALSELY LOW GLUCOSE RESULTS. ONE PATIENT WAS TREATED WITH 1/2 AMP OF GLUCOSE BASED ON RESULT. PATIENT WAS MONITORED AND EXPERIENCED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER LX20 PRO CGA BECKMAN COULTER LX 20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR