BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1790453 · Received July 27, 2007

    Report

    Report Number
    2954323-2007-13551
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 27, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER'S METER HAS BEEN RETURNED TO THE LAB AND PRODUCT TESTING DID NOT CONFIRM THE READINGS COMPLAINT. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. SOME OF THE RESULTS REPORTED BY THE CUSTOMER WERE FOUND IN THE METER'S INTERNAL MEMORY. HOWEVER, THEY WERE NOT ALL COMPLETED WITHIN A 10 MINUTE TIME FRAME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 142, 103, 479, 225 AND 41 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES 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 ABBOTT DIABETES CARE INC, USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK