BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22161102 · Received June 6, 2025

    Report

    Report Number
    3004753838-2025-143448
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 18, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-143448 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. 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) 2025. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT CALLED IN TO REQUEST SENSOR REPLACEMENT FOR A SENSOR THAT SHE HAD TO REMOVE EARLY DUE TO NUMBNESS AT THE INSERTION SITE. THE EVENT OCCURRED THE DAY THE SENSOR HAD BEEN INSERTED IN THE LEFT ARM. PRIOR TO SENSOR INSERTION THE AREA WAS PREPPED WITH ALCOHOL. ON (B)(6) 2025, THE PATIENT EXPERIENCED NUMBNESS AT THE INSERTION SITE, AND IT SPREAD BEYOND THE PATCH PERIMETER IN THE LEFT ARM, AND SHE WAS CONCERNED SHE WAS HAVING A STROKE OR A HEART ATTACK WHICH PROMPTED HER HUSBAND TO TAKE HER TO THE EMERGENCY DEPARTMENT (ED). NO OTHER SYMPTOMS OR UNDERLYING HEALTH CONDITIONS OR MEDICATIONS WERE REPORTED. IN THE ED, HER BLOOD PRESSURE AND BLOOD SUGAR LEVELS WERE WITHIN THE NORMAL RANGE. SHE MENTIONED THE ED PHYSICIAN DID NOT ATTRIBUTE THE NUMBNESS TO THE DEXCOM SINCE THE SENSOR HAD ALREADY BEEN REMOVED NOR DID THEY CONFIRM THE CAUSE OF THE NUMBNESS. IT WAS UNSPECIFIED DURING THE CHRONOLOGY OF THE EVENT WHEN THE SENSOR WAS REMOVED. THE PATIENT RECEIVED PLATELET INHIBITOR MEDICATION PROPHYLAXIS (PLAVIX, UNSPECIFIED DOSAGE) AND WAS ADMITTED TO THE HOSPITAL FOR IN-PATIENT SYMPTOMS MONITORING SINCE THE NUMBNESS DID NOT SUBSIDE. ON (B)(6) 2025 AT 5:00 PM, THE PATIENT WAS DISCHARGED HOME, AND HER BLOOD PRESSURE AND BG LEVELS WERE WITHIN NORMAL RANGE, AND SHE WAS DOING WELL. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462952 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825077003 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other| H