BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24737786 · Received March 30, 2026

    Report

    Report Number
    3004753838-2026-122526
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 1, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-122526 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    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

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. A CORRECTION WAS ENTERED ON (B)(6) 2026. TECHNICAL SUPPORT CLARIFIED THAT THE EVENT WAS ALREADY DOCUMENTED UNDER (B)(4); THEREFORE, THIS SUBMISSION WAS IDENTIFIED AS A DUPLICATE. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SKIN REACTION OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2026. THE DATE OF THE EVENT IS AN APPROXIMATION. THE PATIENT REPORTED EXPERIENCING A SKIN REACTION CHARACTERIZED BY REDNESS AND SORENESS (PAIN) LOCALIZED TO THE OVERPATCH ADHESIVE AREA. THE SENSOR WAS INSERTED ON OR AROUND (B)(6) 2026, AND SYMPTOMS WERE CONFINED TO THE ADHESIVE AREA ONLY, PER THE PATIENT. ON (B)(6) 2026, THE PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT (ED) BY HER HUSBAND DUE TO UNBEARABLE PAIN AT THE AFFECTED SITE. THE PATIENT RETURNED TO THE ED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT AGAIN PRESENTED TO THE EMERGENCY DEPARTMENT FOR CONTINUED SEVERE PAIN, ARRIVING AT APPROXIMATELY 3:00 A.M., TRANSPORTED BY HER HUSBAND. DURING HER ED VISIT, THE PATIENT RECEIVED THE FOLLOWING MEDICATIONS: ORAL HYDROMORPHONE FOR PAIN MANAGEMENT, ZOFRAN (ONDANSETRON), MOTRIN (IBUPROFEN), GABAPENTIN, AND NORCO (HYDROCODONE/ACETAMINOPHEN). THE PATIENT REMAINED IN THE EMERGENCY DEPARTMENT FOR APPROXIMATELY FIVE HOURS AND REPORTED IMPROVEMENT FOLLOWING TREATMENT. THE PATIENT REPORTED SELF-TREATMENT WITH OVER-THE-COUNTER TOPICAL NEOSPORIN, AFTER WHICH THE SKIN REACTION RESOLVED. AT THE TIME OF THIS REPORT, THE PATIENT STATED THAT HER CONDITION HAD IMPROVED AND SHE WAS FEELING WELL. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A 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
    789303 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other MEDICATIONS.