BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1800277 · Received September 28, 2007

    Report

    Report Number
    2954323-2007-18336
    Event Type
    Malfunction
    Date Received
    September 28, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 28, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER RETURNED FREESTYLE FLASH BLOOD GLUCOSE MONITOR WITH (B)(4). NO INDICATIONS OF MEMORY OVERWRITE WERE OBSERVED DURING TESTING. THE CUSTOMER'S PRODUCT (B)(4) HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 4 WHEN A TEST STRIP WAS INSERTED AND A BATTERY AND BOOKLET ICON APPEARED ON THE DISPLAY OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. ALTHOUGH IT IS UNKNOWN IF THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. 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 NA 0633401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK