BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1010149 · Received March 10, 2008

    Report

    Report Number
    2954323-2008-01027
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 6, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DUE TO A BATTERY ISSUE WITH HER SON'S METER HE WAS UNABLE TO TEST HIS BLOOD SUGAR FOR (3) DAYS AND EXPERIENCED SYMPTOMS OF THIRST, DIZZINESS, HEADACHES AND WAS SLEEPY. SHE ALSO REPORTED HE LOST CONSCIOUSNESS WHILE ASLEEP. SHE TESTED HIS BLOOD SUGAR WITH A NEIGHBOR'S METER AND RECEIVED A READING OF 341 MG/DL. SHE CALLED THE PARAMEDICS BECAUSE HER SON "KEPT FALLING ASLEEP AND WAKING UP." SHE GAVE HIM ORANGE JUICE AND THE PARAMEDICS GAVE HIM INSULIN AND MEDICATION THROUGH AN I.V., BUT SHE IS UNSURE WHAT THE MEDICATION WAS. HE WAS TRANSPORTED TO A LOCAL HOSPITAL AND DIAGNOSED WITH HYPERGLYCEMIA. THERE WAS NO REPORT OF PERMANENT IMPAIRMENT IN THIS CASE.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O