BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 2884065 · Received December 21, 2012

    Report

    Report Number
    2954323-2012-06785
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS. INVESTIGATION PERFORMED A CONNECTION TEST ON THE RETURNED TRANSMITTER WITH THE RETURNED RECEIVER AND CONNECTION TEST WAS SUCCESSFUL. THE COMPLAINT WAS NOT CONFIRMED AND A NEW ISSUE WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. SENSOR LOT NUMBER: N1200301, THE DATE OF MANUFACTURE IS UNKNOWN. TRANSMITTER ((B)(4)) MANUFACTURE DATE IS AUGUST 6, 2012. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE INSERTED A NEW SENSOR PRIOR TO CALLING CUSTOMER SERVICE, BUT DID NOT RECEIVE THE "NEW SENSOR DETECTED" RECOGNITION ALERT. AFTER TALKING TO CUSTOMER SERVICE, CUSTOMER INSERTED ANOTHER SENSOR ON (B)(6) 2012 IN THE EVENING, BUT DID NOT RECEIVE THE PROMPT TO CALIBRATE THE NEW SENSOR, BUT NOTED BEING ABLE TO INTERMITTENTLY RECEIVE RESULTS. CUSTOMER REPORTED A READING OF 36 MG/DL WAS OBTAINED ON CUSTOMER'S ADC METER AT NIGHT ON (B)(6) 2012. A READING OF 246 MG/DL WAS OBTAINED ON CUSTOMER'S ADC METER IN THE MORNING AND CUSTOMER REPORTED SELF-TREATING WITH INSULIN AND EATING IN RESPONSE TO THIS READING. CUSTOMER REPORTED THAT AROUND 11 AM ON (B)(6) 2012 SHE EXPERIENCED "WEAKNESS", "CONVULSED" AND THEN LOST CONSCIOUSNESS AND WAS UNABLE TO OBTAIN CONTINUOUS GLUCOSE READINGS FROM HER ADC METER. PARAMEDICS WERE CALLED, TREATED CUSTOMER WITH GLUCOSE BY INJECTION AND TRANSPORTED HER TO A LOCAL HEALTH CARE FACILITY. AT A LOCAL HEALTH CARE FACILITY CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA, A READING OF 38 MG/DL WAS OBTAINED (UNKNOWN SOURCE) AND CUSTOMER WAS TREATED WITH GLUCOSE BY INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM MDS 1268652

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R