BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21257993 · Received January 28, 2025

    Report

    Report Number
    3004753838-2025-024211
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 28, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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).

    Description of Event or Problem · 0

    THE PATIENT REPORTED VIA WEB SELF-SERVICE ON (B)(6) 2025 AND PER FOLLOW UP PHONE CALL MADE BY TECH SUPPORT TO THE PATIENT ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN INFECTION AT THE FIRST SENSOR INSERTION SITE, AND IT SPREAD BEYOND A SECOND SENSOR INSERTION SITE. THIS REPORT CAPTURES THE FIRST SENSOR. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2024. THE EVENT OCCURRED ONE DAY AFTER THE SENSOR HAD BEEN INSERTED IN THE LEFT ARM (TRICEPS AREA). PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. THE PATIENT DEVELOPED REDNESS AND INFLAMMATION AT THE FIRST INSERTION SITE AND DECIDED TO REMOVE THE SENSOR AND INSERT THE SECOND SENSOR JUST BELOW THAT SITE. ON (B)(6) 2024, THE SYMPTOMS SPREAD FROM THE FIRST INSERTION SITE UP TOWARDS THE SHOULDER WHICH PROMPTED HIM TO GO TO AN URGENT CARE (UC) CLINIC. THE HEALTH CARE PROVIDER DREW A CIRCLE AROUND THE INFLAMED AREA TO TRACK THE INFECTION AND PRESCRIBED A COURSE OF ORAL ANTIBIOTIC MEDICATION (DOXYCYCLINE, UNSPECIFIED DOSAGE), AND ADVISED THE PATIENT TO GO TO THE ER IF THE SYMPTOMS WORSEN. AT THE TIME OF THE UC VISIT, HE CONFIRMED THERE WAS NO INFLAMMATION OR INFECTION AT THE SECOND INSERTION SITE. ON (B)(6) 2025 AROUND 9 AM, THE INFECTION SPREAD DOWN THE LEFT SHOULDER, BEYOND THE SECOND SENSOR INSERTION SITE, AND TO THE ELBOW AND THE PATIENT DECIDED TO GO TO THE EMERGENCY ROOM (ER). HE WAS ADMITTED INTO THE HOSPITAL FOR TREATMENT OF AN INFECTION AND NO OTHER SYMPTOMS WERE REPORTED. HE RECEIVED IV ANTIBIOTICS (VANCOMYCIN, UNSPECIFIED DOSAGE) AND FIVE TO SIX DIFFERENT UNSPECIFIED MEDICATIONS. PHOTOS OF THE SKIN INFECTION IN THE COMPLAINT RECORD WERE REVIEWED. THE PHOTOS SHOW THE PROGRESSION OF THE SKIN INFECTION ON THE LEFT ARM AND PRE AND POST SECOND SENSOR REMOVAL. THE PHOTOS CONFIRMED THE SKIN INFECTION. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY ON (B)(6) 2025. AT THE TIME OF THE FOLLOW UP REPORT THE INFECTION HAD ALREADY SUBSIDED, BUT THE PATIENT DECIDED NOT TO INSERT A NEW SENSOR IN HIS LEFT ARM. A PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA PHOTOGRAPHIC INSPECTION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396735 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824219002

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other| H