BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2179856 · Received July 27, 2011

    Report

    Report Number
    2954323-2011-03995
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    October 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1163224) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A HIGH READING ON HER FREESTYLE LITE BLOOD GLUCOSE METER WHEN COMPARED TO A READING FROM A HEALTH CARE PROFESSIONAL'S METER. THE CUSTOMER REPORTED THAT SHE WAS AT HER BOYFRIEND'S HOUSE ON (B)(6), 2011 AT 9:00AM WHEN SHE EXPERIENCED A LOSS OF CONSCIOUSNESS AND SEIZURE. THE CUSTOMER WAS UNRESPONSIVE, AND PARAMEDICS WERE CALLED. A READING OF 20 MG/DL WAS OBTAINED ON THE PARAMEDIC'S METER AT 9:00AM, AND A READING OF 220 MG/DL WAS OBTAINED USING THE CUSTOMER'S FREESTYLE METER AT 9:01AM. THE CUSTOMER WAS TREATED WITH GLUCOSE GEL BY THE PARAMEDICS, BUT WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. NO SELF-TREATMENT WAS REPORTED. 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 1163224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R