BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1550491 · Received December 3, 2009

    Report

    Report Number
    2954323-2009-02098
    Event Type
    Malfunction
    Date Received
    December 3, 2009
    Date of Event
    November 9, 2009
    Report Date
    December 30, 2009
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, CUSTOMER'S PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. AS THE CUSTOMER'S DEVICE AND REPORTED TEST STRIP LOT HAVE NOT YET BEEN RECEIVED FOR INVESTIGATION, A DHR OF STRIP LOT 0974310 WAS REQUESTED AND PERFORMED. NO ERRORS OR FAILURES WERE NOTED AND ALL TESTS PERFORMED WERE WITHIN RANGE SPECIFICATION PRIOR TO FINAL INSPECTION AND SHIPMENT OF PRODUCT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE IS RETURNED AND INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED RECEIVING ERRATIC READINGS ON AN ADC BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 440 MG/DL AND 37 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND REPORTED THE CUSTOMER RECEIVED ERRATIC READINGS ON HER BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 3.6 MMOL/L, 14.8 MMOL/L, AND 10.9 MMOL/L 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, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0974310

    Patients

    Seq Age Sex Outcome Treatment
    1