BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22472865 · Received July 10, 2025

    Report

    Report Number
    3004753838-2025-178949
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 15, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. THIS REPORT IS 1 OF 4 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. RELATED RECORDS: (B)(4).

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL. H2 CORRECTION/ADDITIONAL INFORMATION. H6 TYPE OF INVESTIGATION - ADDITIONAL. H6 INVESTIGATION FINDINGS - CORRECTION. H6 INVESTIGATION CONCLUSION - CORRECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON 06/30/2025, IT WAS REPORTED THAT THE PATIENT STATED THAT SHE HAD BEEN HOSPITALIZED FOUR TIMES FOR DKA AND WAS USING THE G6 SENSOR DURING THOSE EPISODES. THIS REPORT IS 1 OF 4 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. WHILE THE TECHNICIAN WAS ATTEMPTING TO ASK FURTHER QUESTIONS ABOUT WHAT HAPPENED, THE CALL WAS DISCONNECTED. FOLLOW-UP CALLS WERE MADE ON 06/30/2025, 07/5/2025, 07/6/2025, AND 07/7/2025; HOWEVER, ALL CALLS WERE ROUTED TO VOICEMAIL. A REACH-OUT EMAIL WAS ALSO SENT TO REQUEST ADDITIONAL INFORMATION ABOUT THE HOSPITALIZATION, BUT THE PATIENT HAS NOT YET RESPONDED. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION BECAME AVAILABLE. IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE DATE OF EVENT IS AN APPROXIMATION. ON 06/30/2025, IT WAS REPORTED THAT THE PATIENT STATED THAT SHE HAD BEEN HOSPITALIZED FOUR TIMES FOR DKA AND WAS USING THE G6 SENSOR DURING THOSE EPISODES. THIS REPORT IS 1 OF 4 ALLEGATIONS OF INSUFFICIENT INFORMATION FOR COMPLAINT CLASSIFICATION THAT HAD SIMILAR EVENT DETAILS. WHILE THE TECHNICIAN WAS ATTEMPTING TO ASK FURTHER QUESTIONS ABOUT WHAT HAPPENED, THE CALL WAS DISCONNECTED. FOLLOW-UP CALLS WERE MADE ON 06/30/2025, 07/5/2025, 07/6/2025, AND 07/7/2025; HOWEVER, ALL CALLS WERE ROUTED TO VOICEMAIL. A REACH-OUT EMAIL WAS ALSO SENT TO REQUEST ADDITIONAL INFORMATION ABOUT THE HOSPITALIZATION, BUT THE PATIENT HAS NOT YET RESPONDED. PERFORMANCE DATA WAS REVIEWED, ALERTS/NOTIFICATIONS FUNCTIONED AS INTENDED. THE ALLEGATION IS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED; HOWEVER HIGH COUNTS ABERRATION WAS OBSERVED ON 7/02/25 AT 7:05 AM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729213 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| O