BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1152825 · Received September 4, 2008

    Report

    Report Number
    2954323-2008-02487
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 5, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE F/U REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EPISODE OF LOSS OF CONSCIOUSNESS OCCURRED IN 2008, DUE TO MISSING CALIBRATOR AND BLISTER PACK, HENCE BEING UNABLE TO CALIBRATE HER METER AND TEST. SHE REPORTED SELF-TREATING WITH FOOD TO STABILIZE HER BLOOD GLUCOSE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. NI 43185

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other