BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1181742 · Received September 18, 2008

    Report

    Report Number
    2954323-2008-02575
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS PRECISION XTRA BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF "LO" (A 'LO' DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL) AND 171 MG/DL WITHIN 10 MINS. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT 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 42248

    Patients

    Seq Age Sex Outcome Treatment
    1 NI