BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16587984 · Received March 21, 2023

    Report

    Report Number
    3004753838-2023-061575
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    October 20, 2022
    Report Date
    April 6, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LABELING INDICATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (E.G. REDNESS, SWELLING, BRUISING, ITCHING, SCARRING OR SKIN DISCOLORATION). CODES: MEDICAL DEVICE PROBLEM CODE: 2993 ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. CODES: MEDICAL DEVICE PROBLEM CODE: CORRECTION TO DISREGARD 3191 APPROPRIATE TERM/CODE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2023-061575 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    DEXCOM WAS MADE AWARE ON 02/20/2023, THAT ON (B)(6) 2022, THE PATIENT EXPERIENCED A SKIN REACTION. THE SENSOR WAS INSERTED INTO THE ARM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN REACTION WHICH OCCURRED WHEN THE SENSOR HAD BEEN INSERTED IN THE ARM. THE PATIENT DEVELOPED A RASH, REDNESS, INFLAMMATION, BLISTERS, AND A SCAR UNDERNEATH THE SENSOR PATCH. THE PATIENT HAD ITCHING AND BURNING SENSATION IN THE AREA. PRIOR TO SENSOR INSERTION THE AREA WAS CLEANSED WITH SOAP AND WATER. THE REACTION AREA WAS KEPT CLEAN AND DRY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS 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
    938159 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| S