BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1052437 · Received May 21, 2008

    Report

    Report Number
    2954323-2008-01907
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION DID NOT CONFIRM THE COMPLAINT. NO NEW ISSUES WERE OBSERVED, ALL RESULTS WERE WITHIN RANGE SPEC, THE STANDARD DEVIATION WAS WITHIN SPEC AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XTRA METER. THE CUSTOMER REPORTED THEY OBTAINED READINGS OF 20 MG/DL AND 226 MG/DL WITHIN A 10 MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS REPORTED FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE LIMITED UK NI 43001

    Patients

    Seq Age Sex Outcome Treatment
    1 NI