BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1800503 · Received August 31, 2007

    Report

    Report Number
    2954323-2007-16242
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER FREESTYLE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 2.4 MMOL/L, 7.9 MMOL/L AND 15.6 MMOL/L WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER ADDITIONALLY REPORTED ON 07 AUG 2007, THAT WHILE WAITING FOR REPLACEMENT PRODUCT, SHE HAD BEEN GUESSING ON HOW TO PROPERLY DOSE HER MEDICATION. THE CUSTOMER REPORTED SWEATING PROFUSELY, TWITCHING, SHAKING AND EXPERIENCING CRAMPS. THE CUSTOMER WAS TAKEN TO A LOCAL HOSPITAL. EXACT DIAGNOSIS AND TREATMENT WHILE AT THE HOSPITAL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 0701640

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK