BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22515472 · Received July 15, 2025

    Report

    Report Number
    3004753838-2025-185369
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 15, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHED SENSOR WIRE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT DEVELOPED SORENESS AND REDNESS AT THE INSERTION SITE, AND HE DECIDED TO REMOVE THE SENSOR EARLY. UPON SENSOR REMOVAL, THE PATIENT ALLEGED THAT THE SENSOR WIRE DETACHED FROM THE SENSOR POD AND REMAINED IN THE SKIN AND THE AREA APPEARED INFECTED. ON (B)(6) 2025, THE PATIENT CONSULTED HIS PRIMARY CARE PHYSICIAN WHO ADVISED HIM TO GO TO THE EMERGENCY DEPARTMENT (ED). IN THE ED, HE HAD AN X-RAY (UNSPECIFIED RESULT) AND AN INCISION AND DRAINAGE (HALF INCH CUT) AT THE NEEDLE PUNCTURE SITE. THE INCISION AREA WAS DISINFECTED WITH ALCOHOL, THEN OVER THE COUNTER NEOSPORIN OINTMENT AND A BANDAGE WERE APPLIED TO THE AREA. HE WAS DISCHARGED HOME WITH A PRESCRIPTION OF ORAL ANTIBIOTIC MEDICATION (KEFLEX UNSPECIFIED TABLETS, THREE TIMES A DAY FOR SEVEN DAYS. AT THE TIME OF THE REPORT, THE INFECTION HAD ALREADY HEALED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168393 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other