BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1070204 · Received July 3, 2008

    Report

    Report Number
    2954323-2008-02198
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    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 FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED IMPRECISE READINGS ON HER PRECISION XTRA METER. CUSTOMER REPORTED THAT ON THE EVENING OF 2008, SHE REC'D A "FALSE" HIGH READING OF 270MG/DL, DOSED WITH INSULIN AND STATED HER BLOOD GLUCOSE "WENT DOWN INTO THE 50'S". SHE EXPERIENCED SYMPTOMS OF THIRST, WAS SWEATY AND SHAKY. SHE SELF-TREATED WITH GLUCOSE TABLETS TO HELP ALLEVIATE HER SYMPTOMS. SHE ALSO STATED EARLY THE NEXT MORNING SHE WOKE UP AND REPORTED RECEIVING READINGS OF 270 MG/DL, 52 MG/DL AND 50 MG/DL OBTAINED WITHIN A TEN-MINUTE TIMEFRAME. WHEN PLOTTED ON THE PARKES ERROR GRID, THE RESULTS FELL WITHIN THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES ARE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF THIRD-PARTY MEDICAL INTERVENTION, DIAGNOSIS, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH 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 42840

    Patients

    Seq Age Sex Outcome Treatment
    1 NI