BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1033137 · Received April 22, 2008

    Report

    Report Number
    2954323-2008-01553
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH THE COMPLAINT COULD NOT BE DUPLICATED, READINGS VERY SIMILAR TO THE READINGS REPORTED BY THE CUSTOMER WERE FOUND IN THE METER'S MEMORY. (485 MG/DL, 115 MG/DL AND 126 MG/DL WITHIN 10 MINS).

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 126 MG/DL, 115 MG/DL, AND A "HI" WITHIN 10 MINS. ALL TESTS WERE PERFORMED ON THE FINGER. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0717420

    Patients

    Seq Age Sex Outcome Treatment
    1 NI