BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1771037 · Received July 27, 2010

    Report

    Report Number
    2954323-2010-00997
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 18, 2010
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT ONCE INVESTIGATION RESULTS ARE AVAILABLE. REMEDIAL ACTION (B) (4) 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 DOOR 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. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY OBSERVED A CRACK AND MOISTURE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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