BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1800485 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16291
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT 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 MESSAGE ON THEIR LOCKED FREESTYLE FLASH METER. DURING THE COURSE OF TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS DISCOVERED THAT THE UNIT OF MEASURE COULD BE CHANGED. THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. THE CUSTOMER REPORTED THEY FELT LIGHT-HEADED AND SHAKY DUE TO THE INABILITY TO TEST. THERE WAS NO REPORT OF THIRD PARTY MEDICAL INTERVENTION, 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 NI 0705821

    Patients

    Seq Age Sex Outcome Treatment
    1 NI