BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 809163 · Received January 12, 2007

    Report

    Report Number
    2954323-2007-00180
    Event Type
    Malfunction
    Date Received
    January 12, 2007
    Date of Event
    September 26, 2006
    Report Date
    January 12, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC. USA
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED. MEMORY OVERWRITE WAS OBSERVED. FOUND CALIBRATION PARAMETERS RESET, ERRORS INDICATING BATTERY DROOP, OR READINGS IN THE GLUCOSE LOG WITH CAL CODE OF 18. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 3 UPON TEST STRIP INSERTION ON THEIR FREESTYLE BLOOD GLUCOSE MONITOR. DURING RETURNED PRODUCT TESTING, IT WAS DISCOVERED THAT THE UNIT OF MEASUREMENT COULD BE CHANGED FROM MMOL/L TO MG/DL. 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 LFR ABBOTT DIABETES CARE INC. USA NA 0530642

    Patients

    Seq Age Sex Outcome Treatment
    1 YR