BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 2676575 · Received July 31, 2012

    Report

    Report Number
    2954323-2012-06429
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 3, 2012
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1172414) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. ADDITIONALLY, SIMILAR READINGS FROM THE ONES REPORTED BY THE CUSTOMER WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG; HOWEVER, IT IS UNKNOWN IF THE READINGS OCCURRED IN 10 MINUTES DUE TO THE CUSTOMER NOT SETTING THE DATE AND TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 390 MG/DL AND 65 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
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW 1172414

    Patients

    Seq Age Sex Outcome Treatment
    1