BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1630044 · Received March 12, 2010

    Report

    Report Number
    2954323-2010-00299
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 23, 2010
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TRANSMITTER ((B) (4)) WAS VISUALLY INSPECTED AND CONFIRMED TO HAVE CRACKS IN THE BATTERY AREA. LEAK TESTING WAS ALSO PERFORMED TO DETERMINE IF THE CRACKS ALLOW FOR MOISTURE PENETRATION. THE RETURNED TRANSMITTER FAILED LEAK TESTING. REMEDIAL ACTION 2954323-04/14/2009-002-C WAS REPORTED TO THE (B) (4) DISTRICT OFFICE ON 14 APR 2009.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SENT ONCE INVESTIGATION RESULTS ARE AVAILABLE. REMEDIAL ACTION 2954323-04/14/2009-002-C WAS REPORTED (B) (4) ON 14 APR 2009.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. UPON VISUAL INSPECTION OF THE RETURNED PRODUCT, A CRACK/FRACTURE WAS OBSERVED ON 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK FINAL LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD CAREGIVER (CG) PUSH IN BAG SPIKE, GIVE HALF TURN, MOVE CLAMP AND RUB LINE, FLIP BAG AND PRESS GO. THE CG STATED THAT THE FINAL LINE DID NOT SEEM TO BE SPIKED ALL THE WAY UNTIL TSR HAD CG PUSH ON IT. THE HC MACHINE PRIMED AND THE HOME PATIENT (HP) CONNECTED AND BEGAN THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(6) 2010 REGARDING FINAL LINE NOT BEEN SPIKED ALL THE WAY, IT WAS REVEALED THAT THE HP DID NOT REPORT ANY LOOSE CONNECTION OR LEAK. THE NURSE CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT ON OR AROUND (B)(6) 2010. THE NURSE STATED THAT THE HP DID NOT REPORT ANY DEFECTS ON THE SUPPLIES. PER NURSE, THE HP DISCARDS THE CASSETTES AFTER THERAPY. THE NURSE STATED THAT THE HP WAS SEEN IN THE CLINIC TODAY ((B)(6) 2010), AND WAS DOING FINE AND CONTINUING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER 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