BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE PRECISION QID GLUCOSE METER

    MDR report key: 321887 · Received March 14, 2001

    Report

    Report Number
    1220459-2001-00073
    Event Type
    Malfunction
    Date Received
    March 14, 2001
    Date of Event
    February 12, 2001
    Report Date
    March 12, 2001
    Manufacturer
    MEDISENSE
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ROUTINE INVESTIGATION WHEN A COMPLAINT WAS RECEIVED THAT A LOWER BLOOD GLUCOSE VALUE OF 178 MG/DL WAS RECEIVED ON A CUSTOMER'S PRECISION QUD METER WHEN COMPARED TO A LAB RESULT OF 248 MG/DL. WHEN THESE RESULTS WERE PLOTTED ON A CLARKE ERROR GRID, THE ANALYSIS FELL INTO THE "D" ZONE SHOWING THEM TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11291 MEDISENSE PRECISION QID GLUCOSE METER BLOOD GLUCOSE METER CFR MEDISENSE NA 85460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN