BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 737227 · Received July 10, 2006

    Report

    Report Number
    2954323-2006-00469
    Event Type
    Malfunction
    Date Received
    July 10, 2006
    Date of Event
    June 13, 2006
    Report Date
    July 10, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER'S METER AND TEST STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XTRA METER. THE CUSTOMER OBTAINED READINGS OF 101, 120, 322, 71 AND 341 MG/DL WITHIN A 10 MIN TIMEFRAME. WHEN PLOTTING EACH OF THE READINGS AGAINST THE AVERAGE ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'B' AND 'C' ZONES. ONE RESULT FELL IN THE 'C' ZONE INDICATING THE DIFFERENCE IN READINGS TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE INC. * 40848

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN