BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 841798 · Received October 13, 2006

    Report

    Report Number
    2954323-2006-01043
    Event Type
    Malfunction
    Date Received
    October 13, 2006
    Date of Event
    August 4, 2006
    Report Date
    October 13, 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

    THE METER WAS CONFIRMED TO HAVE EXHIBITED MEMORY OVERWRITE. TESTED RETURNED UNIT. NO MFG PARAMETERS FOUND OUT OF SPEC AND CIG PANASONIC BATTERY VOLTAGE WAS MEASURED AT 2.975V. DID NOT OBSERVE BATTERY ICON OR BOOKLET ICON WHILE STRIP WAS INSERTED. HOWEVER, UOM WAS SELECTABLE AND WAS REC'D AT MMOL/L. 0300, 0800, 0204 AND 0015 ERRORS WERE OBSERVED IN THE ERROR LOG INDICATING BATTERY DROOP. METER IS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS HAVING INCORRECT UNIT OF MEASURE ON HER ADC METER. THE CUSTOMER ALSO REPORTS SEEING A BATTERY ICON AND HAVING OTHER SETTINGS OF THE ADC METER CHANGED WHICH INDICATES A POTENTIAL MEMORY OVERWRITE ISSUE. NO DEATH OR SERIOUS INJURY WAS REPORTED.

    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 YR