BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 4250950 · Received November 14, 2014

    Report

    Report Number
    2954323-2014-01111
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    MDS
    PMA / PMN Number
    P050020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FREESTYLE TRANSMITTER HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF PRODUCT IS RETURNED. HOWEVER, THE CUSTOMER REPORTED THEY HAVE ALREADY DISPOSED THE TRANSMITTER. NOTE:THE DEVICE MANUFACTURER DATE FOR THE REPORTED TRANSMITTER IS UNKNOWN. REMEDIAL ACTION 2954323-04/14/2009-002-C WAS REPORTED TO THE (B)(4) DISTRICT OFFICE ON 14 APR 2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HIS TRANSMITTER IS BROKEN ON THE OUTSIDE, THE BATTERY DOOR AND THE "NIPPEL" OF THE 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
    736747 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM MDS ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1