BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 14075170 · Received April 11, 2022

    Report

    Report Number
    3004753838-2022-042950
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    February 23, 2022
    Report Date
    April 11, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORTER EMAIL ADDRESS - (B)(6). THIS MDR WAS PREVIOUSLY SUBMITTED ON 03/21/22 AT 01:16 PM PST WITH MFR# 3004753838-2022-042950. THE ACK2 WAS RECEIVED ON 03-21-2022, 16:21:37 WITH COREID: (B)(4) DAY 26. PER CDRH/CESUB, ¿WE ARE UNABLE TO LOCATE THE BELOW SUBMISSIONS. THEY WERE NOT RECEIVED. PLEASE CHECK YOUR SUBMISSIONS FOR ANY ISSUES, REPACKAGE THEM PROPERLY AND RESUBMIT THEM.¿ AS PER ESG/CDRH EMAIL ON 3/18/2022, THIS SUBMISSION IS CONSIDERED A TIMELY SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2022. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE POTENTIAL PATIENT MISUSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490165 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 5295656

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose