BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 3870809 · Received June 12, 2014

    Report

    Report Number
    2954323-2014-00657
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Product Code
    NBW
    PMA / PMN Number
    K080960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED WITH CONTROL TEST STRIPS. AFTER FURTHER INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE DEVICE MANUFACTURE DATE FOR THE REPORTED METER SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. HEALTH PROFESSIONAL REPORTED RECEIVING A READING OF 7.2 MMOL/L COMPARED TO A LAB RESULT OF 4 MMOL/L WITHIN 10 MINUTES. 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
    346921 PRECISION XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1