BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1161239 · Received September 10, 2008

    Report

    Report Number
    2954323-2008-02529
    Event Type
    Injury
    Date Received
    September 10, 2008
    Date of Event
    August 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER'S FRIEND REPORTED THAT CUSTOMER'S METER WAS SHOWING ERROR MESSAGES, AND AS A RESULT, THE CUSTOMER WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA. THE CUSTOMER'S FRIEND REPORTED THE CUSTOMER WAS TAKEN TO A HOSPITAL AND TREATED WITH INTRAVENOUS FLUIDS AND INSULIN. THE CUSTOMER'S FRIEND DID NOT REPORTEDLY KNOW IF THE CUSTOMER WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA. 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NI 42269

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R