BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE INSULINX

    MDR report key: 2973064 · Received February 21, 2013

    Report

    Report Number
    2954323-2013-00122
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. SIMILAR READINGS, 2 OF THE 3, TO THE ONES THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 304 MG/DL, 250 MG/DL AND 85 MG/DL 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
    76372 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1254929

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR