BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1766282 · Received July 21, 2010

    Report

    Report Number
    2954323-2010-00970
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 21, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE DEVICE (B) (4) HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETAINED TEST STRIPS (LOT NO: 1002834) AND RETAINED CONTROL SOLUTION (LOT NO: 9F3P11) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. THE METER POWERED ON WITH THE BUTTON AND WITH INSERTION OF A TEST STRIP. ADDITIONALLY, ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ER-3 MESSAGE ON THE DISPLAY OF HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER ON (B) (6) 2010 AND NOTED THE TEST WOULD NOT START WITH TEST STRIP INSERTION. SHE FURTHER REPORTED SELF-ADMINISTERING AN UNKNOWN AMOUNT OF INSULIN, WHICH WAS NOT A CHANGE TO HER NORMAL MEDICATIONS AND SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. NO THIRD-PARTY EMERGENT INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED WITH ORANGE JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0936301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other