BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6513784 · Received April 22, 2017

    Report

    Report Number
    3004753838-2017-40027
    Event Type
    Malfunction
    Date Received
    April 22, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 23, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000323
    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). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER, RECEIVER, AND SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER WAS CHARGED AND REBOOTED. THE RECEIVER LOG WAS DOWNLOADED FOR EVALUATION, NO FIRMWARE ERRORS RELATED TO CUSTOMER COMPLAINT WERE OBSERVED. HOWEVER, A REVIEW OF THE RECEIVER LOG SHOWED COMMUNICATION GAPS WHICH CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION. ALSO A TRANSMITTER DEVICE ( SERIAL #(B)(4), LOT #6000880) WAS RETURNED TO MANUFACTURER ON 04/18/2017 AND WAS RECEIVED BY MANUFACTURER ON 05/18/2017. THE TRANSMITTER DEVICE WAS EVALUATED, A VISUAL INSPECTION FOUND NO DEFECTS. THE SHARE LOG DATA WAS RETRIEVED AND EVALUATED. THE CUSTOMER COMPLAINT FOR LOSS OF CONNECTION WAS CONFIRMED AFTER A DETAILED LOG REVIEW, HOWEVER THE TRANSMITTER BEHAVED AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296129 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22949 NI 00386270000323

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR