BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1803167 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16270
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 2, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED 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 DEVICE WAS RETURNED AND THE INVESTIGATION REVEALED THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS ARE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS REPORTED BY THE CUSTOMER WERE NOT FOUND IN THE METER'S INTERNAL MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 52 MG/DL AND 400 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 LIMITED UK NI 42205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK