BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 781899 · Received November 9, 2006

    Report

    Report Number
    2954323-2006-01265
    Event Type
    Malfunction
    Date Received
    November 9, 2006
    Date of Event
    August 3, 2006
    Report Date
    November 9, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. NO MANUFACTURING PARAMETERS FOUND OUT OF SPEC AND FRESH PANASONIC BATTERY VOLTAGE WAS MEASURED AT 3.096V. DID NOT OBSERVE BATTERY ICON OR BOOKLET ICON WHILE STRIP WAS INSERTED. UNIT OF MEASURE WAS SELECTABLE AND WAS REC'D A MMOL/L. 0300, 0806, AND 0015 ERRORS WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROOP. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FMA 05/16/06 LETTER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR 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