BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1972024 · Received January 27, 2011

    Report

    Report Number
    2954323-2011-01217
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 27, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER (B)(4) WAS RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION DURING THE CONTROL SOLUTION TESTING. THIS IS THE FINAL REPORT. NOTE: THE RESULTS OF THE READINGS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "B" ZONE SHOWING THE DIFFERENCE IN VALUES WAS NOT CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE RECEIVED READINGS "ALL OVER THE PLACE" ON HER FREESTYLE LITE BLOOD GLUCOSE METER. THE FOLLOWING READINGS WERE REPORTEDLY OBTAINED WITHIN TEN MINUTES: 148 MG/DL, 126 MG/DL, 267 MG/DL, 134 MG/DL AND 118 MG/DL. IT WAS ALSO REPORTED THE CUSTOMER LOST CONSCIOUSNESS AND PARAMEDICS WERE CALLED. THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE ORALLY AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1025013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other