BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1031831 · Received April 18, 2008

    Report

    Report Number
    2954323-2008-01525
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 18, 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'S HEALTH CARE PROVIDER REPORTED CUSTOMER RECEIVED ERRATIC GLUCOSE READINGS FROM THEIR PRECISION XTRA METER. CUSTOMER'S HEALTH CARE PROVIDER REPORTED CUSTOMER EXPERIENCED SYMPTOMS OF DIAPHORESIS AND LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED, AND THEY TRANSPORTED CUSTOMER TO HOSPITAL WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. THERE IS NO REPORT ON TREATMENT GIVEN AT THE HOSPITAL; 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R