BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 6125493 · Received November 23, 2016

    Report

    Report Number
    3004753838-2016-52192
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000156
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND PASSED. ADDITIONALLY THE TRANSMITTER (PART NUMBER STT-GL-003 /SERIAL NUMBER (B)(4)/LOT NUMBER 5211632) WAS ALSO RETURNED, THE TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND PASSED. DATA LOG WAS UNAVAILABLE FOR REVIEW ON THE TRANSMITTER, HOWEVER A REVIEW OF THE DOWNLOADED DATA LOG FROM THE RECEIVER CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER. REPORTEDLY, THE PEDIATRIC PATIENT WAS USING AN ADULT RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. BOTH THE RECEIVER AND TRANSMITTER WAS RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. LABELING INDICATES: THE DEXCOM SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777059 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22495 5211970 00386270000156

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR