BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7945170 · Received October 8, 2018

    Report

    Report Number
    3004753838-2018-120353
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 26, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 07/26/2018 THAT ON (B)(6) 2018, THE SMART DEVICE DISPLAYED AN ERROR MESSAGE FOR LOW TRANSMITTER BATTERY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR INVESTIGATION. DATA INVESTIGATION CONFIRMED A LOW TRANSMITTER BATTERY IN ADDITION, A FAILED TRANSMITTER ERROR WAS PRESENT IN CONNECTION TO THE REPORTED ALLEGATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED ISSUE OF LOW TRANSMITTER BATTERY IS REPORTABLE BASED ON THE FINDING OF A FAILED TRANSMITTER ERROR. THE TRANSMITTER HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-120353.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785478 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6006865

    Patients

    Seq Age Sex Outcome Treatment
    1