BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA MONITOR

    MDR report key: 376159 · Received February 5, 2002

    Report

    Report Number
    1220459-2002-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2002
    Date of Event
    January 9, 2002
    Report Date
    February 4, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION IDENTIFIED A HIGHER READING OF 150 MG/DL ON A MEDISENSE PRECISION XTRA MONITOR WHEN COMPARED TO A LABORATORY RESULT OF 60 MG/DL. WHEN THESE VALUES ARE PLOTTED ON A CLARK ERROR GRID, THEY FALL INTO THE "C" ZONE WHICH IS CONSIDERED TO BE CLINICALLY SIGNIFICANT. NO DEATH, INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA MONITOR BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 50204

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other