BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1020834 · Received May 30, 2007

    Report

    Report Number
    2954323-2007-09069
    Event Type
    Malfunction
    Date Received
    May 30, 2007
    Date of Event
    April 30, 2007
    Report Date
    May 30, 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

    THE PRODUCT WAS RECEIVED AND TESTING COULD NOT DUPLICATE THE CUSTOMER'S COMPLAINT. ALL RESULTS WERE WITHIN RANGE SPECS AND NO NEW ERRORS WERE OBSERVED DURING CONTROL SOLUTIONS TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS ON HIS PRECISION XTRA BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS OF 'LO','LO','LO', AND 114MG/DL WITHIN A TEN MINUTE TIMEFRAME A 'LO' MESSAGE INDICATES A BLOOD GLUCOSE READING LESS THAN 20 MG/DL. ALL READINGS WERE TAKEN FROM THE FINGER. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'C' ZONE, WHICH SHOWS THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 41078

    Patients

    Seq Age Sex Outcome Treatment
    1 NI