BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7449924 · Received April 22, 2018

    Report

    Report Number
    3004753838-2018-042762
    Event Type
    Malfunction
    Date Received
    April 22, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 23, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED:

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 A LOSS OF CONNECTION HAD OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION HOWEVER DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED: DEXCOM WAS MADE AWARE ON 3/232018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION HAD OCCURRED. SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION BECAME AVAILABLE: IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED, HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM. LABELING INDICATES THAT THE DEXCOM CGM APPLICATION IS ONLY COMPATIBLE FOR SELECT DEVICES AND OPERATING SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292550 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR