BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1886489 · Received October 29, 2010

    Report

    Report Number
    2954323-2010-01499
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 29, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B)(4) WAS RETURNED AND TESTED WITH TEST STRIPS LOT # 0964803. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION. ADDITIONALLY, THE REPORTED READINGS OF 2.1 MMOL/L (37 MG/DL), 3.9 MMOL/L (70 MG/DL), AND 9.5 MMOL/L (171 MG/DL) WERE FOUND IN THE DEVICE'S INTERNAL MEMORY LOG WITHIN 10 MINUTES ON (B)(6) 2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 2.1 MMOL/L, 3.9 MMOL/L, AND 9.5 MMOL/L WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0964803

    Patients

    Seq Age Sex Outcome Treatment
    1