BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24488265 · Received March 2, 2026

    Report

    Report Number
    3004753838-2026-101822
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 2, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2026. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EPISODES OF SIGNAL LOSS AND BRIEF SENSOR ERRORS. AT AN UNSPECIFIED TIME, THE PATIENT¿S BG WAS TESTED WITH A GLUCOMETER WHICH WAS 298 MG/DL. THE PATIENT WAS TREATED WITH 15 UNITS OF INSULIN VIA INJECTION. THE PATIENT WAS ALSO WEARING A TANDEM INSULIN PUMP. THE FOLLOWING DAY, ON (B)(6) 2026, THE PATIENT DEVELOPED FLU SYMPTOMS AND THE PATIENT¿S MOTHER BROUGHT THE PATIENT TO URGENT CARE. THE PATIENT WAS PRESCRIBED AN UNSPECIFIED FLU MEDICATION AND THEN SENT HOME. AROUND THIS TIME, THE PATIENT¿S CGM PROVIDED A SENSOR FAILED ALERT (CAPTURED IN THIS COMPLAINT). ONCE AT HOME, THE PATIENT BECAME VERY WEAK AND WAS UNABLE TO STAND. THE PATIENT VOMITED REPEATEDLY AND WAS UNABLE TO KEEP ANY FLUIDS DOWN. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) FOR EVALUATION. AT THE ER, THE PATIENT¿S BG METER READING WAS 450 MG/DL AND THE PATIENT WAS DIAGNOSED WITH DKA. THE PATIENT WAS ADMITTED TO THE ICU AND STARTED ON AN IV INSULIN DRIP AND THREE OTHER UNSPECIFIED IV LINES. THE PATIENT¿S MOTHER WAS UNCERTAIN OF WHAT THE OTHER MEDICATIONS WERE. THE PATIENT WAS EXPECTED TO STAY IN THE ICU FOR ANOTHER 5-10 DAYS. AT THE TIME OF REPORT, THE PATIENT WAS STILL HOSPITALIZED WITH ¿SLIGHT IMPROVEMENT¿ AND THE PATIENT¿S BG LEVEL WAS RANGING BETWEEN 190-230 MG/DL. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE VERY LOW COUNT ABERRATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552095 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725279009 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Hospitalization| O TANDEM TSLIM PUMP.