BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA MONITOR

    MDR report key: 378799 · Received February 22, 2002

    Report

    Report Number
    1220459-2002-00012
    Event Type
    Malfunction
    Date Received
    February 22, 2002
    Date of Event
    February 1, 2002
    Report Date
    February 2, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION IDENTIFIED A HIGHER READING OF 203 MG/DL ON A MEDISENSE PRECISION XTRA MONITOR WHEN COMPARED TO A LABORATORY RESULT OF 32 MG/DL. WHEN THESE VALUES ARE PLOTTED ON A CLARKE ERROR GRID, THEY FALL INTO THE "E" ZONE WHICH IS CONSIDERED TO BE CLINICALLY SIGNIFICANT. NO DEATH OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA MONITOR BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 50387

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other