BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 831359 · Received March 13, 2007

    Report

    Report Number
    2954323-2007-02784
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    February 13, 2007
    Report Date
    March 13, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED. PERFORMED INVESTIGATION. METER IS UNLOCKED TO MMOL/LS. READINGS WITH AN 13 CAL CODE WERE FOUND IN GLUCOSE LOG. ERRORS 015, 0204, 0300 AND 0806 WERE FOUND IN ERROR LOG. CALIBRATION PARAMETERS WERE WITHIN SPECIFICATION. MEMORY OVERWRITE WAS OBSERVED. METER IS INOPERABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE UNIT OF MEASURE SETTING ON THEIR UNLOCKED FREESTYLE FLASH METER HAD 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 YR