BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1810151 · Received October 12, 2007

    Report

    Report Number
    2954323-2007-19378
    Event Type
    Malfunction
    Date Received
    October 12, 2007
    Date of Event
    September 12, 2007
    Report Date
    October 12, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOT BEING ABLE TO TEST BLOOD GLUCOSE DUE TO THE LANCING DEVICE NOT PUNCTURING HER FINGER. CUSTOMER REPORTED LOSS OF CONSCIOUSNESS AND NOT "WAKING UP". CUSTOMER'S HUSBAND CALLED PARAMEDICS AND THE CUSTOMER WAS TAKEN TO UNIVERSITY OF CHICAGO EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. THE TREATMENT ADMINISTERED TO STABILIZE BLOOD GLUCOSE IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization