BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1786911 · Received August 5, 2010

    Report

    Report Number
    2954323-2010-01076
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 5, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER (SERIAL # (B)(4)) AND TEST STRIPS (LOT # 0914029) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION DURING THE CONTROL SOLUTION TESTING. ALTHOUGH IT WAS REPORTED THAT THE READINGS OF 455 MG/DL AND 114 MG/DL WERE OBTAINED WITHIN TEN MINUTES, THOSE READINGS WERE NOT FOUND IN THE METER'S MEMORY LOG WITHIN A TEN MINUTE TIMEFRAME. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THE CUSTOMER RECEIVED WITHIN TEN MINUTES THE FOLLOWING ERRATIC READINGS ON THEIR BLOOD GLUCOSE METER: 455 MG/DL AND 114 MG/DL. IT WAS ADDITIONALLY REPORTED THE CUSTOMER EXPERIENCED TREMULOUSNESS UPON RECEIVING THE READING OF 114 MG/DL. THE CUSTOMER REPORTEDLY EXPERIENCED SEIZURE. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CALLER REPORTED THE CUSTOMER TOOK THEIR REGULAR DIABETES MEDICATION (METFORMIN). RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 0914029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other