BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7741637 · Received August 1, 2018

    Report

    Report Number
    3004753838-2018-078472
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    May 11, 2018
    Report Date
    March 4, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PFQ
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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)(4) 2018, THAT ON (B)(6) 2018, A PAIRING FAILURE BETWEEN THE TRANSMITTER, RECEIVER, AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW DID NOT CONFIRM THE REPORTED EVENT OF PAIRING FAILURE. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED ISSUE OF PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF TRANSMITTER FAILURE ERROR.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A VOLTAGE MEASUREMENT WAS TAKEN AND FAILED AT 0 VDC. A SHARE LOG REVIEW WAS PERFORMED AND A FAILURE TO PAIR WAS FOUND. A FATAL ERROR WAS OBSERVED FOR A DIFFERENT TX ID (B)(4) AND IS NOT RELATED TO THIS INVESTIGATION. THE ALLEGED TRANSMITTER HAS ALREADY BEEN SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581918 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF PFQ DEXCOM, INC. 9438-06 6004138 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR