BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1636866 · Received March 22, 2010

    Report

    Report Number
    2954323-2010-00342
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 24, 2010
    Report Date
    May 24, 2010
    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 INVESTIGATION RESULTS ARE AVAILABLE. REMEDIAL ACTION (B) (4) WAS REPORTED TO THE (B) (4) OFFICE ON 14 APR 2009.

    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 (B) (4) WAS REPORTED TO THE (B) (4) DISTRICT OFFICE ON 14 APR 2009. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERRATIC READINGS OF 215 MG/DL AND 380 MG/DL ON HIS FREESTYLE FREEDOM LITE METER AND SELF-DOSING WITH 60 UNITS OF HUMALOG MIX 75/25, WHICH RESULTED IN A HYPOGLYCEMIC EPISODE WITH LOSS OF CONSCIOUSNESS. THE CUSTOMER REPORTEDLY SELF-TREATED WITH ORANGE JUICE TO COUNTERACT THE EVENT. NO THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THE RESULTS WHEN PLOTTED ON PARKES ERROR GRID FELL INTO A "B" ZONE SHOWING THE DIFFERENCE IN VALUES BEING CLINICALLY INSIGNIFICANT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    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