BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17431359 · Received July 31, 2023

    Report

    Report Number
    3004753838-2023-149953
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 10, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT, 3004753838-2023-152986 IS NOT A SERIOUS INJURY AND IS BEING DOWNGRADED TO A MALFUNCTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, UPON FURTHER REVIEW OF THE COMPLAINT RECORD, THE PATIENT WAS HOSPITALIZED FOR THE REPORTED SKIN REACTION THAT RESULTED IN AN INFECTION WHICH WAS REPORTED UNDER 3004753838-2023-152986. THIS REPORT, 3004753838-2023-152986 IS NOT A SERIOUS INJURY AND IS BEING DOWNGRADED TO A MALFUNCTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DETACHED SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2023. ON (B)(6) 2023, THE PEDIATRIC PATIENT EXPERIENCED A DETACHED SENSOR WIRE WHICH OCCURRED 2 DAYS AFTER THE SENSOR HAD BEEN INSERTED IN THE ARM. THE PATIENT EXPERIENCED DETACHED WIRE AND AN INFECTION ON THE INSERTION SITE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND THERE THEY PRESCRIBED ANTIBIOTICS. THERE WAS NO INFORMATION IF THE WIRE WAS STUCK OR REMOVED FROM THE PATIENT´S SKIN AND HOW. DUE DILIGENCE ATTEMPTS TO CONTACT THE REPORTER FOR MORE INFORMATION WERE ATTEMPTED BUT NOT SUCCESSFUL. NO PRODUCT 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
    1843376 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 5325431

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Other CAMDIAB PUMP