BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM LITE

    MDR report key: 1574529 · Received January 11, 2010

    Report

    Report Number
    2954323-2010-00033
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 13, 2009
    Report Date
    January 25, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B) (4) AND STRIP LOT # 0925228 WERE RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. A SIMILAR READING AS REPORTED BY CUSTOMER WAS FOUND IN THE METER MEMORY PRECEEDING THE MEDICAL EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A GLUCOSE RESULT OF 128 MG/DL ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER IN 2009 AT 8:00 AM. IT WAS FURTHER REPORTED CUSTOMER BECAME UNRESPONSIVE, NON-VERBAL AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND THEY RECEIVED A READING OF 13 MG/DL ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS UNABLE TO STATE HOW MUCH TIME HAD ELAPSED BETWEEN THE READING OBTAINED ON THE ADC METER AND THE READING FROM THE PARAMEDICS. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY AND DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER REPORTED RECEIVING TREATMENT, BUT WAS UNABLE TO STATE WHAT TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    WHILE PERFORMING AN INVESTIGATION ON A CUSTOMER'S FREESTYLE NAVIGATOR TRANSMITTER, A CRACK WAS OBSERVED ON THE BATTERY DOOR LATCHES. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0925228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention