BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH GLUCOSE METER

    MDR report key: 372795 · Received January 15, 2002

    Report

    Report Number
    1220459-2002-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Report Date
    January 14, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THAT A CONSUMER RECEIVED A READING OF 17.4 MMOL/L (315 MG/DL) WHEN COMPARED TO A LABORATORY COMPARISON OF 6.3 MMOL/L (114MG/DL). WHEN THESE VALUES ARE PLOTTED ON A CLARKE ERROR GRID, THE RESULTS FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTECH GLUCOSE METER BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 45749

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other