BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1162169 · Received September 15, 2008

    Report

    Report Number
    2954323-2008-02554
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMERS METER HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING IMPRECISE SEQUENTIAL READINGS ON THEIR METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 1.8 MMOL/L, 13.3 MMOL/L, AND 1.2 MMOL/L WITHIN A 10-MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FELL IN THE 'C' ZONE, RESULTS IN THIS ZONE ARE DEEMED CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 42920

    Patients

    Seq Age Sex Outcome Treatment
    1 NI