BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1651823 · Received April 6, 2010

    Report

    Report Number
    2954323-2010-00428
    Event Type
    Malfunction
    Date Received
    April 6, 2010
    Date of Event
    March 4, 2010
    Report Date
    April 6, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER (B) (4) AND TEST STRIPS (LOT # 0935516) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THE READING OF 98 MG/DL WAS FOUND IN THE METER MEMORY LOG ((B) (6) 2010, 4:24 PM). NO REPORT IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B) (6) 2010 SHE HAD A BLOOD GLUCOSE LAB TEST AT 4:22 PM WITH A RESULT OF 48 MG/DL, AND COMPARED THAT RESULT TO A READING OF 98 MG/DL SHE OBTAINED ON HER BLOOD GLUCOSE METER AT 4:24 PM. THE RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES WAS 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 0935516

    Patients

    Seq Age Sex Outcome Treatment
    1