BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2280822 · Received October 6, 2011

    Report

    Report Number
    2954323-2011-04702
    Event Type
    Injury
    Date Received
    October 6, 2011
    Date of Event
    September 22, 2011
    Report Date
    December 19, 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 PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    RETURNED METER AND TEST STRIPS WERE INVESTIGATED AND ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS OR NEW ISSUES WERE OBSERVED DURING CONTROL SOLUTION TESTING. ADDITIONALLY, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1170818) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS OR NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING ON HER FREESTYLE LITE METER OF 195 MG/DL AT 8PM ON (B)(6), 2011 THAT WAS LOWER THAN SHE FELT. AS A RESULT OF THE READINGS ISSUE, THE CUSTOMER REPORTED SHE "FELT LIKE SHE WAS DRUNK AND SLEEPY, AND EXPERIENCED PASSING OUT." THE CUSTOMER STATED SHE COULD NOT REMEMBER THE TIME OF HER SYMPTOMS AND LOSS OF CONSCIOUSNESS. THE CUSTOMER DENIED ANY THIRD-PARTY MEDICAL INTERVENTION, AND INDICATED SHE SHE SELF-TREATED WITH INSULIN (TYPE AND DOSAGE NOT REPORTED), IN ADDITION TO "DIET SODA". THERE IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1170818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other