BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1012326 · Received February 11, 2008

    Report

    Report Number
    2954323-2008-01044
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FOLLOW-UP WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 6 MESSAGE ON HIS PRECISION XTRA BLOOD GLUCOSE METER AND WAS UNABLE TO TEST FOR (4) DAYS AND SUBSEQUENTLY EXPERIENCED SEVERE SHAKING AND GOT "DIZZY AND WEAK" AT NOON TIME ON THE FOUR DAYS, HE WAS UNABLE TO TEST. HE STATES HE WAS SEEN AT A LOCAL HEALTH CARE FACILITY, WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS TREATED WITH 500 MG OF HUMULIN R, (HUMULIN IS ADMINISTERED AS UNITS/ML NOT MG.) IN ADDITION HE REPORTED DRINKING MILK, EATING PASTA AND HAMBURGER MEAT TO HELP ALLEVIATE HIS SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE. IT SHOULD BE NOTED THE TREATMENT REPORTED IS INCONSISTENT WITH THE REPORTED DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 42402

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other