BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1172060 · Received September 23, 2008

    Report

    Report Number
    2954323-2008-02607
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. 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 THEY WERE UNABLE TO TEST IN THEIR FREESTYLE LITE METER AND WENT INTO A DIABETIC COMA. CUSTOMER DID NOT RECALL EXPERIENCING ANY SYMPTOMS PRIOR TO THE EVENT. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH GLUCAGONS. CUSTOMER WAS THEN TRANSPORTED TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND BEING TREATED WITH UNK MEDICATION. AT THE POINT OF CUSTOMER CONTACT THE CUSTOMER STATED THAT THE FREESTYLE LITE METER WOULD NOT START AFTER A BLOOD SAMPLE WAS APPLIED, HOWEVER, IT IS UNK AT THIS TIME IF THIS ISSUE WAS OCCURRING AT THE TIME OF THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization