BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA / OPTIUM

    MDR report key: 1022580 · Received April 1, 2008

    Report

    Report Number
    2954323-2008-01276
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    January 12, 2008
    Report Date
    April 1, 2008
    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

    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 HIS BLOOD GLUCOSE BECAUSE HIS PRECISION XTRA METER WAS NOT CODED PROPERLY. CUSTOMER ALSO REPORTED THAT HE WAS IN A DIABETES COMA FOR FOUR DAYS. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO HOSPITAL, WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. THE TREATMENT AT THE HOSPITAL IS UNKNOWN, AN INVESTIGATION INTO THE DETAILS OF THIS EVENT IS IN PROCESS.

    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 42470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R