BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 792838 · Received December 1, 2006

    Report

    Report Number
    2954323-2006-01464
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    September 28, 2006
    Report Date
    December 1, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TESTED RETURNED UNIT. COMPLAINT CONFIRMED. NO MANUFACTURING PARAMETERS FOUND OUT OF SPEC. DID NOT OBSERVE BATTERY ICON OR BOOKLET ICON WHILE STRIP WAS INSERTED. HOWEVER, UOM WAS SELECTABLE AND WAS RECEIVED AT MMOL/DL. ERROR 015, 0204 AND 0300 WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROOP. METER IS OPERABLE. CUSTOMERS AND RETAILS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UOM SETTING OF THEIR UNLOCKED FREESTYLE FLASH METER CHANGED FROM MMOL/L TO MG/DL. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. 70658-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN