BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22569243 · Received July 22, 2025

    Report

    Report Number
    MW5173070
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 17, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE HOSPITALIZED DUE TO FAILURE OF THE DEXCOM G7 TO ALERT ABOUT HYPERGLYCEMIA PROBLEMS: USE THE BELOW APPROPRIATE INSULIN ORDER SETS IN EPIC, INCLUDING: INSULIN ORDER SET: IP (INPATIENT) ADULT SUBCUTANEOUS (SQ) INSULIN HYPOGLYCEMIA PROTOCOL ORDER SET: IP ADULT HYPOGLYCEMIA IN THE HOSPITAL, CONSIDER: LONG-ACTING (BASAL) INSULIN: GLARGINE 20 UNITS EVERY 24 HOURS. RAPID-ACTING (BOLUS) INSULIN: LISPRO 3 UNITS QAC (BEFORE EVERY MEAL) (HOLD IF PATIENT IS NOT EATING). RAPID-ACTING CORRECTION LISPRO INSULIN: LISPRO LOW UNIT CORRECTION QAC (TO BE GIVEN WITH PRE-MEAL BOLUS TO CORRECT FOR HYPERGLYCEMIA. RAPID-ACTING BEDTIME CORRECTION LISPRO INSULIN: LOW UNIT CORRECTION HS (AT BEDTIME). PLEASE CHECK GLUCOSE QAC/QHS (EVERY NIGHT AT BEDTIME) (IF ORDERED FOR A PO (BY MOUTH) DIET). INPATIENT TARGET GLUCOSE 140-180MG/DL. OF NOTE, HYPOTHYROIDISM AND ADDISON DISEASE LISTED IN HIS MEDICAL RECORD FROM (B)(6) (BY MOUTH). PT HAD ADRENOCORTICOTROPIC HORMONE STIMULATION TEST BEFORE WITH APPROPRIATE CORTISOL RESPONSE, THUS DOES NOT HAVE ADRENAL INSUFFICIENCY. ALSO, HAS HISTORICALLY NORMAL TFT (THYROID FUNCTION TEST) WITHOUT LEVOTHYROXINE REPLACEMENT THERAPY, THEREFORE, DOES NOT HAVE HYPOTHYROIDISM. WOULD CONSIDER REVIEWING/DELETING THIS MISLEADING DIAGNOSIS FROM HIS RECORDS IF CONSIDERED APPROPRIATE BY HIS PROVIDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726008 G7 CONTINUOUS GLUCOSE MONITORING SYSTEM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. 0038627000214

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization| L