BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11822746 · Received May 13, 2021

    Report

    Report Number
    3004753838-2021-86790
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    September 3, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QDK
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H2- CORRECTION. H10- CORRECTED DATA. 3004753838 - 2021 - 86790 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

    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.

    Additional Manufacturer Narrative · 1

    (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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6)2021, THAT ON (B)(6) 2021, THE PATIENT EXPERIENCED A SKIN REACTION.  THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6)2021. THE PATIENT STATED ITCHING, BURNING, RASH, REDNESS, INFLAMMATION, BLISTERS, DRY SKIN, AND SCAR OCCURRED. AT THE TIME OF CONTACT, IT WAS INDICATED THAT THE PATIENT WAS STABLE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715550 DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QDK DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR