BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1241258 · Received November 18, 2008

    Report

    Report Number
    2954323-2008-02883
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 5, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER'S BOYFRIEND REPORTED THAT THE CUSTOMER RECEIVED A READING OF 77 MG/DL IN 2008, WHICH WAS HIGHER THAN HOW SHE FELT. THE CUSTOMER ALSO FELT "GAGGY, CONFUSED, AND WAS NOT SURE WHETHER OR NOT SHE HAD A SEIZURE." THE PARAMEDICS WERE CALLED AND AFTER TESTING HER BLOOD GLUCOSE, INSTRUCTED HER TO EAT AND GAVE HER GLUCAGON. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0812824

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention