BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1770483 · Received June 12, 2007

    Report

    Report Number
    2954323-2007-10280
    Event Type
    Malfunction
    Date Received
    June 12, 2007
    Date of Event
    May 15, 2007
    Report Date
    June 12, 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). THE PRODUCT HAS BEEN REQUESTED. IT WILL BE INVESTIGATED UPON RETURN AND A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS ON THEIR FREESTYLE FLASH BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS 360 MG/DL AND 60 MG/DL WITHIN A TEN MINUTE TIMEFRAME. ALL READINGS WERE TAKEN FROM THE FINGER. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'C' ZONE, WHICH SHOWS THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. CUSTOMER REPORTED THE FOLLOWING SYMPTOMS: VOMITING AND "SYMPTOMS OF LOW GLUCOSE", TREATED WITH "SODA". IT SHOULD BE NOTED CUSTOMER "DOES NOT KNOW" IF HE WASHED HIS HANDS OR SQUEEZED THE SITE PRIOR TO TESTING.

    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 0636124

    Patients

    Seq Age Sex Outcome Treatment
    1 NI