BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE METER

    MDR report key: 376091 · Received February 5, 2002

    Report

    Report Number
    1220459-2002-00008
    Event Type
    Malfunction
    Date Received
    February 5, 2002
    Date of Event
    December 19, 2001
    Report Date
    February 4, 2002
    Manufacturer
    MEDISENSE, INC
    Product Code
    CFR
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH REPORT WAS RECEIVED STATING THAT A HIGH BLOOD GLUCOSE READING OF 570 MG/DL WAS OBTAINED ON A MEDISENSE PCX BLOOD GLUCOSE METER WHEN COMPARED TO A LABORATORY VALUE OF 291 MG/DL. WHEN THESE VALUES ARE PLOTTED ON A CLARKE ERROR GRID, THEY FALL INTO THE "C" ZONE WHICH IS CONSIDERED TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MALFUNCTION ASSOCIATED WITH THE EVENT. AN INAPPROPRIATE CORRECTIVE ACTION OF GIVING THE PT AN ADDITIONAL SNACK WAS REPORTED AND VERIFIED BY A FOLLOW-UP COMMUNICATION TO THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other