BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 2162760 · Received July 14, 2011

    Report

    Report Number
    2954323-2011-03850
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 30, 2011
    Report Date
    November 2, 2011
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT ONCE ADDITIONAL INFORMATION IS OBTAINED. REMEDIAL ACTION 2954323-04/14/2009-002-C WAS REPORTED TO THE (B)(4) DISTRICT OFFICE ON 14 APR 2009.

    Additional Manufacturer Narrative · 1

    RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND CONFIRMED TO HAVE CRACKS IN THE BATTERY AREA AND THERMISTOR AREA. LEAK TESTING WAS ALSO PERFORMED. THE RETURNED TRANSMITTER PASSED LEAK TESTING. BASED ON THESE RESULTS, THIS ISSUE IS NOT ASSOCIATED WITH REMEDIAL ACTION 2954323-04/14/2009-002-C.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY OBSERVED A CRACK IN THEIR FREESTYLE NAVIGATOR TRANSMITTER. IT HAS BEEN DETERMINED THAT SOME FREESTYLE NAVIGATOR TRANSMITTERS COULD POTENTIALLY EXHIBIT A CRACK/FRACTURE ON THE PLASTIC HOUSING NEAR THE BATTERY COMPARTMENT, WHICH COULD POTENTIALLY ALLOW MOISTURE TO COME IN CONTACT WITH THE TRANSMITTER'S INTERNAL ELECTRONICS, POTENTIALLY CAUSING THE TRANSMITTER AND THE RECEIVER TO LOSE CONNECTION INTERRUPTING THE CONTINUOUS GLUCOSE RESULTS. ALTHOUGH UNLIKELY, MOISTURE ENTERING THE TRANSMITTER HAS THE POTENTIAL TO GENERATE INACCURATE RESULTS ONLY WITH THE CONTINUOUS GLUCOSE READINGS. THE BUILT-IN FREESTYLE GLUCOSE METER IS NOT IMPACTED BY THIS ISSUE AND THE USER CAN CONTINUE TO USE THE BUILT-IN METER. 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 NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM LFR

    Patients

    Seq Age Sex Outcome Treatment
    1