BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1161246 · Received September 11, 2008

    Report

    Report Number
    2954323-2008-02534
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 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

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HIS BLOOD SUGAR DROPPED TOO LOW WITH SUBSEQUENT LOSS OF CONSCIOUSNESS. HE ADDITIONALLY REPORTED RECEIVING TWO READINGS ON HIS FS FREEDOM LITE METER, 118 MG/DL AND 29 MG/DL (CONSISTENT WITH A LOSS OF CONSCIOUSNESS), WITHIN TEN-MINUTES OF EACH OTHER. THE READINGS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES IS NOT CONSIDERED CLINICALLY SIGNIFICANT. HE ALSO REPORTEDLY RECEIVED EMERGENCY GLUCOSE, THOUGH IT IS UNCLEAR WHO ADMINISTERED THE GLUCOSE. CUSTOMER DENIED THIRD-PARTY MEDICAL INTERVENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0812830

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention