BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15178252 · Received August 5, 2022

    Report

    Report Number
    3004753838-2022-142138
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    June 29, 2022
    Report Date
    November 2, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001627
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION D9: DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION D9: DATE DEVICE RETURNED - ADDITIONAL INFORMATION H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3A: DEVICE EVALUATED BY MFG- ADDITIONAL INFORMATION. H3B: EVALUATION INCLUDED - ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION. THIS MDR WAS PREVIOUSLY SUBMITTED ON 9/22/2022 WITH MFR# 3004753838-2022-142138-01. THE ACK2 WAS RECEIVED ON 9/23/2022 BY CDRH WITH COREID: (B)(6) ON 9/30/2022, THE CESUB HELPDESK HAS COMMUNICATED THEY ARE AWARE OF MULTIPLE MDRS THAT FAILED TO PROCESS AND MULTIPLE ACK3S THAT FAILED TO SEND BETWEEN SEPTEMBER 7 AND SEPTEMBER 26 DUE TO AN INFRASTRUCTURE ISSUE, AND THEY ARE WORKING AS FAST AS THEY CAN TO REPROCESS THE MDRS THAT NEED TO BE REPROCESSED AND RESEND ACK3S THAT FAILED TO SEND. THEIR GOAL IS TO COMPLETE THIS TASK AND RESPOND TO ALL OPEN ACK3 TICKETS BY OCTOBER 7. AS OF OCTOBER 28, 2022, THE ISSUE HAS NOT BEEN RESOLVED. AS PER ESG/CDRH EMAIL ON 10/28/2022, WE SHOULD NOW RESUBMIT THIS MDR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND PASSED. PAIRING AND DOWNLOAD TEST WITH NORDIC BLUETOOTH DEVICE WAS PERFORMED AND PASSED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602320 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 P13091768 00386270001627

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male