BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7471452 · Received April 29, 2018

    Report

    Report Number
    3004753838-2018-045807
    Event Type
    Malfunction
    Date Received
    April 29, 2018
    Date of Event
    February 25, 2018
    Report Date
    March 31, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS.  THE FOLLOWING REPORTS ARE BEING SUBMITTED:  180401-000162,180401-000165,180401-000170,180401-000175,180401-000199,180401-000201,180401-000203,180401-000207,180401-000219,180401-000225,180401-000230,180401-000246,180401-000252,180401-000257,180401-000260,180401-000267,180401-000271,180401-000276,180401-000291,180401-000295,180401-000297,180401-000305,180401-000308,180401-000310,180401-000312,180401-000316,180401-000322,180401-000335,180401-000343,180401-000348,180401-000351,180401-000354,180401-000358,180401-000370,180401-000376,180401-000382,180401-000388,180401-000394,180401-000403,180401-000406,180401-000410,180401-000417,180401-000423,180401-000427,180401-000429,180401-000438,180401-000458,180401-000466,180401-000477,180401-000479,180401-000489,180401-000493,180401-000505,180401-000507,180401-000512,180401-000516,180401-000519,180401-000522,180401-000532,180401-000538,180401-000557,180401-000562,180401-000565,180401-000570,180401-000580,180401-000587,180401-000590,180401-000602,180401-000608,180402-000049.

    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 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

    IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314125 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR