BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1880712 · Received October 25, 2010

    Report

    Report Number
    2954323-2010-01473
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    February 17, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED CUSTOMER RECEIVED A READING OF 156 MG/DL FROM THEIR FREESTYLE FREEDOM BLOOD GLUCOSE METER AND SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER DID NOT KNOW IF HE EXPERIENCED ANY SYMPTOMS PRIOR TO LOSING CONSCIOUSNESS. CUSTOMER'S WIFE REPORTED CALLING THE PARAMEDICS WHO OBTAINED A READING OF 41 MG/DL FROM THEIR HCP METER AND TREATED CUSTOMER WITH JUICE. CUSTOMER WAS THEN TRANSPORTED TO A HEALTH CARE FACILITY WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. IT IS UNKNOWN IF ADDITIONAL TREATMENT WAS PROVIDED AT THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1016916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other