BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XCEED

    MDR report key: 1023853 · Received April 2, 2008

    Report

    Report Number
    2954323-2008-01295
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED OBTAINING TWO SETS OF HIGH READINGS ON A PRECISION XTRA METER. THE CUSTOMER REPORTED THEY OBTAINED A READING OF 500 MG/DL COMPARED TO A LAB READING OF 74 MG/DL AND A READING OF 390 MG/DL COMPARED TO A LAB READING OF 181 MG/DL, ALL READINGS WERE TAKEN WITHIN A 10 MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL INTO THE "D" ZONE AND "C" ZONE RESPECTIVELY, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF A SERIOUS INJURY, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XCEED BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 42359

    Patients

    Seq Age Sex Outcome Treatment
    1 NI