BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20107647 · Received August 30, 2024

    Report

    Report Number
    3004753838-2024-220058
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 27, 2024
    Report Date
    September 17, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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). THIS IS 2 OF 2 REPORTS OF SKIN REACTION IN WHICH EACH EVENT HAS SIMILAR DETAILS AND TREATMENT BUT OCCURRED ON TWO DIFFERENT SENSORS. PLEASE SEE RELATED RECORDS (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-220058 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 08/02/2024, THAT ON (B)(6) 2024, THE PATIENT EXPERIENCED A SKIN REACTION. DATE OF EVENT IS AN APPROXIMATION. THE PATIENT EXPERIENCED A SKIN REACTION WITH ITCHING AND REDNESS EXTENDED BEYOND THE PATCH PERIMETER, WHICH OCCURRED AFTER THE SENSOR HAD BEEN INSERTED IN THE ARM. THIS REPORT IS TO CAPTURE THE 2ND SKIN REACTION IN WHICH EACH EVENT HAS SIMILAR DETAILS AND TREATMENT BUT OCCURRED ON TWO DIFFERENT SENSORS. PER FOLLOW UP WITH THE PATIENT ON (B)(6) 2024, THE REACTION WAS TREATED WITH A PRESCRIPTION OF ORAL MEDICATION; ANTIBIOTICS, STRONG CORTISONE, FLU FOXT 5. THE PATIENT USED OVER THE COUNTER STICKER BARRIER (CUTIDERM) AS BARRIER PRODUCT BUT IT DID NOT HELPED TO MINIMIZE OR PREVENT THE SKIN REACTION. THEY DID AN ALLERGIES TEST THAT TOOK ONE MONTH TO GIVE THE RESULT BACK, IT WAS A SUSPECTED BACTERIAL INFECTION BUT WAS NOT CONFIRMED. NO DATA OR PRODUCT WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. 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. THE ISSUE WAS ALREADY DOCUMENTED UNDER (B)(4). 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
    1795111 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other