BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1012323 · Received February 11, 2008

    Report

    Report Number
    2954323-2008-01040
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ERROR 4 MESSAGE DISPLAYED ON HIS FREESTYLE FLASH BLOOD GLUCOSE MONITOR. AS A RESULT, CUSTOMER REPORTS LOSING CONSCIOUSNESS AND HAVING A SEIZURE. NO THIRD PARTY MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER DID NOT REPORT TAKING ANYTHING TO AMELIORATE THE SYMPTOMS.

    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 0729923

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other