BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 2914516 · Received January 14, 2013

    Report

    Report Number
    2954323-2013-00022
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 23, 2012
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED COMPARING AN ADC METER READING OF 354 MG/DL TO A LAB RESULT OF 99 MG/DL. THE BLOOD TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL IN THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES WAS 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
    20785 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001H620

    Patients

    Seq Age Sex Outcome Treatment
    1