BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 23531945 · Received November 12, 2025

    Report

    Report Number
    MW5178719
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 7, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THREE DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SENSORS FROM THE SAME LOT NUMBER FAILED WITHIN MINUTES OF THE INITIAL WARM-UP PERIOD. ALL THREE SENSORS CAME FROM LOT #1825116002 (LBL-1003893 REV 008, MANUFACTURED IN (B)(6). THE FAILURES OCCURRED ON (B)(6) 2025, AND EACH UNIT DISPLAYED SENSOR ERROR MESSAGES SHORTLY AFTER ACTIVATION, NEVER PROVIDING VALID GLUCOSE READINGS. DEXCOM TECHNICAL SUPPORT WAS CONTACTED ON 11/7/2025, BUT BOTH THE REPRESENTATIVE AND SUPERVISOR (B)(4) DISMISSED THE ISSUE WITHOUT ESCALATION, STATING IT WAS "DULY NOTED." NO FURTHER INVESTIGATION OR REPLACEMENT WAS OFFERED. BECAUSE THREE CONSECUTIVE FAILURES CAME FROM THE SAME LOT, THIS MAY REPRESENT A MANUFACTURING OR QUALITY CONTROL ISSUE THAT COULD IMPACT OTHER USERS. PHOTOS OF THE PRODUCT BOXES AND LOT LABELS ARE AVAILABLE AND CAN BE PROVIDED UPON REQUEST. NO LABORATORY DATA APPLICABLE. THIS REPORT CONCERNS REPEATED DEVICE FAILURES OF THE DEXCOM G7 CONTINUOUS GLUCOSE MONITOR, NOT A TEST RESULT. PATIENT CODE: 4580. DEVICE CODES: 1535, 2591, 1506. REFER TO ADD'L DOCUMENTS IN I2K. REF REPORTS: MW5178720, MW5178721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932224 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. G7 1825116002

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female LANTUS 15-20 UNIT (2 X 1 MORNING-1 NIGHT TIME)| ANASTROZOLE 1MG TABLETS, ONE TABLET BY MOUTH ONE TIME EACH DAY. | ANTI-DEPRESSANT PREGABALIN 100MG (2 X 1 MORNING-1 NIGHT TIME | ARIMIDEX LEVOTHYROXINE .075 MG (75 MCG) ONE TIME A DAY IN THE MORNING BEFORE ANY FOOD AND WATER ON AND EMPTY STOMACH STARTED (B)(6)-FOR THYROID | BLOOD THINNER BUDESONIDE-FORMOTEROL AKA-SYMBICORT 2PUFFS EACH TIME -| CARVEDILOL 3.125 MG 2X MORNING N NIGHT FOR HBP | CARVEDILOL 6.25 MG 2X MORNING N NIGHT | CLOPIDOGREL (PLAVIX) 75 MG - 1 TIME A DAY. | CULTURELLE DIGESTIVE DAILY | DOXEPIN 10 MG 1X DAY | FERROUS SULFATE 325MG FOR IRON DEFICIENCY / OTC | FOLIC ACID 1MG 1X- FOR IRON| FUROSEMIDE 20 MG 1X - WATER PILL / OTC | HEART MED N POTASSIUM JARDIANCE -HEART AND DIABETES 10MG 1X| INHALER 160-4.5 MCG/ACT 2X MORNING N NIGHT FOR COPD | LANTUS 15-20 UNITS -1 X AT NIGHT TIME| LEADS - 694765 (B)(6) 2004 2 STENTS SEE PICS BREAST BIOPSY RIGHT SIDE MARKERS (B)(6) 2024 | LEFLUNOMIDE USP 10MG - 1 TIME A DAY (B)(6)- FOR RA | LOSARTIN 25MG 1X MORNING | LYRICA CALCIUM 600 MG OTC W VIT D 20 MG -EVERY OTHER DAY (B)(6) 2025| LYRICA ROSUVASTATIN 40 MG 1X CHOLESTEROL ( AKA CRESTOR)| MEDTRONIC VISIA AF MRI - DVFB1D1 | METHOCARBAMOL 500 MG FOR LEGS CRAMPS (2 X1 MORNING-1 NIGHT TIME)MUSCLE RELAXER | METHOCARBAMOL 500MG FOR LEG CRAMPS (2 X 1 MORNING-1 NIGHT TIME) AS NEEDED| NIGHT TIME BUDESONIDE-FORMOTEROL -2 PUFFS -INHALER 160-4.5 MCG/ACT 2XMORNING N NIGHT| NOVOLOG 5-10 UNITS AT DINNER OR AS NEEDED | ONDANSETRON ODT 4MG AS ONLY AS NEEDED FOR NAUSEA | PANTOPRAZOLE 40 MG EC 1X FOR STOMACH| PREGABALIN 100MG (2 X 1 MORNING-1 NIGHT TIME) FOR FIBROMYALGIA- | PROBIOTIC OTC | RECEIVED TETANUS SHOT ON | SULFASALAZANE 500MG TABLETS NEW RA MEDS STARTED 10/29 | TRAMADOL 50 MG - FOR PAIN | ULTRACOR "TWIRL" MARKER (B)(4) LOT HUHZ0756