BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 833125 · Received March 29, 2007

    Report

    Report Number
    2954323-2007-03713
    Event Type
    Injury
    Date Received
    March 29, 2007
    Date of Event
    February 26, 2007
    Report Date
    March 29, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND AN INVESTIGATION HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. PERFORMED INVESTIGATION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. DOWNLOADED GLUCOSE LOG. COMPARED DOWNLOADED LOG WITH THE GLUCOSE HISTORY IN THE METER. DID NOT OBSERVE INCORRECT DATA IN MEMORY. HOWEVER, DUE TO THE SERIOUS NATURE OF THE ADVERSE EVENT, A REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED TWO SEPARATE INCIDENTS WITH THE SAME METER INVOLVING "SUGAR THAT IS JUMPINGG ALL AROUND". IN 2007 CUSTOMER'S "GLUCOSE WENT TO 53 (MG/DL) AND SHE PASSED OUT". SHE WAS "TREATED WITH GLUCOSE". ONE DAY LATER, "SHE FELL TO THE FLOOR" AND AGAIN WAS "TREATED WITH GLUCOSE". ADDITIONAL READINGS REPORTED: 201, 38, 76, 39, 49, 72, 391, 240, 360, 376. IT SHOULD BE NOTED THE READINGS WERE NOT DONE WITHIN 10 MINUTES OF EACH OTHER AND SHE REPORTS EATING IN BETWEEN THE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NI 0617042

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention