BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1970647 · Received January 25, 2011

    Report

    Report Number
    2954323-2011-00943
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 25, 2011
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED AND ON THE RETURNED PRODUCT. VISUAL INSPECTION ON THE TRANSMITTER IDENTIFIED A CRACK AT THE THERMISTOR BARREL. LEAK TESTING WAS THEN PERFORMED TO TEST THE NAVIGATOR TRANSMITTER FOR ACCEPTABLE PRESSURE DECAY (IE: LEAK RATE) OF THE SEALED UNIT. RETURNED TRANSMITTER ((B)(4)) FAILED THE LEAK TEST. (B)(4).

    Description of Event or Problem · 1

    WHILE PERFORMING AN INVESTIGATION ON THE CUSTOMER'S RETURNED FREESTYLE NAVIGATOR TRANSMITTER, A THERMISTOR CRACK WAS OBSERVED. 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 MDS

    Patients

    Seq Age Sex Outcome Treatment
    1