BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMES ELITE ANALYZER

    MDR report key: 19765 · Received February 15, 1995

    Report

    Report Number
    MW1005142
    Event Type
    Malfunction
    Date Received
    February 15, 1995
    Date of Event
    January 20, 1995
    Report Date
    February 9, 1995
    Manufacturer
    DIAGNOSTICS DIV. MILES, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CAPILLARY GLUCOSE PERFORMED ON ANALYZER. YIELDED 377 MG/DL VENOUS BLOOD SAMPLE OBTAINED, AT THE SAME TIME YIELDED GLUCOSE VALUE OF 115 MG/DL ON ANOTHER CO'S DEVICE. QUALITY CONTROL CHECKS ON INSTRUMENT WERE WITHIN ACCEPTABLE LIMITS FOR THAT RUN. VENOUS SAMPLE RESULTS CONCURRED WITH PT CONDITION. OTHER CO'S DEVICE QC ACCEPTABLE. REP AT CO HAD NO REASON FOR DISCREPANT RESULTS BY THE INSTRUMENT, SUGGESTING REAGENT STRIP PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMES ELITE ANALYZER GLUCOMETER CFR DIAGNOSTICS DIV. MILES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other AMES GLUCOSE STIRP LOT A4F04CA064 EXP DATE 12/95