BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 797706 · Received December 14, 2006

    Report

    Report Number
    2954323-2006-01647
    Event Type
    Malfunction
    Date Received
    December 14, 2006
    Date of Event
    October 2, 2006
    Report Date
    December 14, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. TESTED RETURNED UNIT. 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 MG/DL. ERRORS 015, 0204, 0300, 0800 AND 0806 WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROOP. METER IS OPERABLE. CUSTOMERS AND RETAILERS 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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN