BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5901326 · Received August 24, 2016

    Report

    Report Number
    3004753838-2016-50461
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    July 29, 2016
    Report Date
    July 29, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000170
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-RR-001 /SERIAL NUMBER (B)(4)/LOT NUMBER 5202783), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON XX/XX/XXXX. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF AN UNRECOVERABLE LOSS OF ANTENNA PASSED THRESHOLD. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553901 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-05 5212111 00386270000170

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR