BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 1973425 · Received January 30, 2011

    Report

    Report Number
    2954323-2011-01285
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 28, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE TEST STRIPS HAVE BEEN RETURNED AND AN INVESTIGATION HAS DETERMINED THE COMPLAINT IS NOT CONFIMED. THE TEST STRIPS WERE FOUND TO PERFORM ACCORDING TO SPECIFICATIONS. IT SHOULD BE NOTED: THE METER IS DESIGNED TO REPORT READINGS OF 1.1 MMOL/L TO 27.8 MMOL/L. THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS GREATER THAN 27.8 MMOL/L.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED RECEIVING A READING FROM THEIR PRECISION XCEED PRO BLOOD GLUCOSE METER WHICH WAS LOWER WHEN COMPARED TO A RESULT RECEIVED FROM THEIR LAB. CUSTOMER REPORTED RECEIVING A READING OF 22.5 MMOL/L COMPARED TO A READING OF 57.0 MMOL/L WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "OUT OF RANGE" 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 XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 44935H

    Patients

    Seq Age Sex Outcome Treatment
    1