BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1781695 · Received June 26, 2007

    Report

    Report Number
    2954323-2007-11272
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    May 29, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF "LO", 175 MG/DL, 210 MG/DL AND 191 MG/DL WITHIN 10 MINS. A "LO" MESSAGE INDICATES A READING LESS THAN 20 MG/DL. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER LFR ABBOTT DIABETES CARE LIMITED UK NI 41293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK