BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA

    MDR report key: 1771062 · Received July 27, 2010

    Report

    Report Number
    2954323-2010-00998
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 23, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER'S REPORTED METER AND TEST STRIPS WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT DID NOT CONFIRM AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THE REPORTED READING OF 191 MG/DL WAS NOT FOUND IN THE METER'S MEMORY LOG. HOWEVER, A SIMILAR READING OF 198 MG/DL WAS FOUND ON 16 JUNE 2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A HIGH READING OF 191 MG/DL ON THEIR BLOOD GLUCOSE MONITOR. THE LABORATORY REFERENCE READING OF 90 MG/DL WAS RECEIVED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A128

    Patients

    Seq Age Sex Outcome Treatment
    1