BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1802257 · Received September 6, 2007

    Report

    Report Number
    2954323-2007-16475
    Event Type
    Malfunction
    Date Received
    September 6, 2007
    Date of Event
    August 7, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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 THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS WAS RECEIVED ON A CUSTOMER'S MEDISENSE/OPTIUM BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS OF 19MG/DL AND 143 MG/DL WITHIN A TEN MINUTE TIMEFRAME. BOTH TESTS WERE PERFORMED ON THE FINGER. WHEN PLOTTING THE READINGS AGAINST THE AVERAGE ON A PARKES ERROR GRID, THE RESULTS FELL IN THE "B" AND "C" ZONES. THE "C" ZONE RESULTS SHOWS THE DIFFERENCE IN READINGS 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 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 40882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA