BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19448282 · Received June 3, 2024

    Report

    Report Number
    3004753838-2024-130758
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    April 30, 2024
    Report Date
    February 21, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM ¿ CORRECTION  H2: TYPE OF FOLLOW UP- CORRECTION  H6: INVESTIGATION FINDINGS - CORRECTION.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-130758 AND 3004753838-2024-130758-01 WERE REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING'S OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. IT WAS INDICATED THAT THE PATIENT REMOVED THE TRANSMITTER FROM THE SENSOR POD BEFORE REMOVING THE SENSOR FROM THE BODY, WHICH IS MISUSE OF THE DEVICE. A PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED VIA PHOTOGRAPHIC INSPECTION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MISSING NEEDLE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2024. IT WAS INDICATED THAT THE PATIENT REMOVED THE TRANSMITTER FROM THE SENSOR POD BEFORE REMOVING THE SENSOR FROM THE BODY, WHICH IS MISUSE OF THE DEVICE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL AND FIRST SUPPLEMENTAL MDR, IT WAS DETERMINED THAT REPORTS WERE SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595080 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 5337381

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male