BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1770710 · Received July 27, 2010

    Report

    Report Number
    2954323-2010-00994
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 3, 2010
    Report Date
    August 24, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER RETURNED METER SERIAL NUMBER (B)(4). THE METER HAS BEEN TESTED WITH AN APPROVED STRIP LOT 1002834. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READINGS REPORTED WERE NOT FOUND IN THE INTERNAL MEMORY LOG OF THE METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 429 MG/DL AND 129 MG/DL 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.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT HE OBTAINED A RESULT OF 113 MG/DL ON THE ADVANTAGE SYSTEM WITH EXPIRED STRIPS AND FELT CONFUSED BEFORE PASSING OUT 15 MINUTES LATER. THE CUSTOMER REPORTED THAT HIS FRIENDS CALLED AN EMERGENCY UNIT, THEY ARRIVED 15 MINUTES LATER, OBTAINED A RESULT OF 25 MG/DL ON THEIR SYSTEM AND TREATED THE CUSTOMER WITH MEDICATION. REPORTER STATED THAT HE WAS TAKEN TO THE HOSPITAL AND GIVEN ORANGE JUICE AND FOOD THERE. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1011502

    Patients

    Seq Age Sex Outcome Treatment
    1