BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1801429 · Received September 25, 2007

    Report

    Report Number
    2954323-2007-17944
    Event Type
    Malfunction
    Date Received
    September 25, 2007
    Date of Event
    August 26, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ABBOTT DIABETES CARE, LTD., UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE COMPLETED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA OPTIUM BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 23 MG/DL, 57 MG/DL, AND 174 MG/DL WITHIN 10 MINUTES. 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. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE, LTD., UK NI 41314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK