BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED PRO

    MDR report key: 2950713 · Received February 8, 2013

    Report

    Report Number
    2954323-2013-00082
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    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. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DATE ENTERED IS THE COMPLAINT AWARENESS DATE.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. THE HEALTHCARE PROFESSIONAL REPORTED COMPARING AND ADC METER READING OF 24 MG/DL TO A LAB RESULT OF 68 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
    54193 PRECISION XCEED PRO BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1