BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7471503 · Received April 29, 2018

    Report

    Report Number
    3004753838-2018-045842
    Event Type
    Malfunction
    Date Received
    April 29, 2018
    Date of Event
    November 24, 2017
    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
    PA, 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: REF: 180401-000341 180401-000339 180401-000338 180401-000334 180401-000332 180401-000323 180401-000318 180401-000293 180401-000292 180401-000290 180401-000287 180401-000285 180401-000284 180401-000280 180401-000277 180401-000275 180401-000244 180401-000243 180401-000241 180401-000238 180401-000233 180401-000227 180401-000224 180401-000198 180401-000197 180401-000196 180401-000195 180401-000193 180401-000189 180401-000187 180401-000186 180401-000181 180401-000177 180401-000169 180401-000164 180401-000160 180401-000121 180401-000116 180401-000111 180401-000096 180401-000093 180401-000089 180401-000070 180401-000069 180401-000066 180401-000063 180401-000057 180401-000053 180401-000047 180331-001163 180331-001152 180331-001144 180331-001135 180331-001130 180331-001122 180331-001111 180331-001104 180331-001094 180331-001083 180331-001078 180331-001071 180331-001065 180331-001053 180331-001045 180331-001039 180331-001027 180331-001016 180331-001009 180331-000999 180331-000981 180331-000970 180331-000882 180331-000866 180331-000855 180331-000844 180331-000828 180331-000802 180331-000789 180331-000782 180331-000773 180331-000759 180331-000742 180331-000726 180331-000715 180331-000704 180331-000692 180331-000681 180331-000673 180331-000666 180331-000652 180331-000638 180331-000572 180331-000547 180331-000539 180331-000530 180331-000522 180331-000515 180331-000507 180331-000497 180331-000491 180331-000483 180331-000473 180331-000466 180331-000452 180331-000445 180331-000437 180331-000429 180331-000422 180331-000408 180331-000396 180331-000385 180331-000381 180331-000369 180331-000362 180331-000354 180331-000341 180331-000333 180331-000320 180331-000311 180331-000298 180331-000291 180331-000283 180331-000276 180331-000261 180331-000253 180331-000241 180331-000233 180331-000221 180331-000215 180331-000197 180331-000190 180331-000187 180331-000184 180331-000180 180331-000174 180331-000172 180331-000166 180331-000135 180331-000129 180331-000124 180331-000116 180331-000058

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 3/31/2018 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. 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. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314147 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR