BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1820887 · Received July 19, 2007

    Report

    Report Number
    2954323-2007-13016
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S METER (B)(4) WAS RETURNED AND PRODUCT TESTING DID NOT CONFIRM THE READINGS COMPLAINT. ALL RESULTS WERE WITHIN RANGE SPECIFICATIONS AND NO ERRORS WERE OBSERVED. THE READINGS REPORTED BY THE CUSTOMER ARE NOT PRESENT IN THE METER'S MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE SEQUENTIAL READINGS ON THEIR MEDISENSE OPTIUM BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 488 MG/DL AND 143 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 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 41636

    Patients

    Seq Age Sex Outcome Treatment
    1 NI