BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1810193 · Received October 24, 2007

    Report

    Report Number
    2954323-2007-20304
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    September 25, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATIONS AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XTRA METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 7.7 MMOL/L AND 1.2 MMOL/L WITHIN A TEN MIN TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FELL WITHIN THE "C" ZONE AND ARE CONSIDERED SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 41220

    Patients

    Seq Age Sex Outcome Treatment
    1 NI