BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1152851 · Received September 5, 2008

    Report

    Report Number
    2954323-2008-02510
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    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 REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE AND A PORT ISSUE WITH THEIR METER AND WERE UNABLE TO TEST. AS A RESULT, THEY EXPERIENCED FEELING DIZZY, HUNGRY, HEADACHE, NERVOUSNESS. THEY WERE SEEN AT A LOCAL HOSPITAL, DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH FLUIDS (SOLUTION UNKNOWN). 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. NI 42044

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention