FDA Adverse Event Injury Summary report: N

DEXCOM G7

MDR report key: 22411603 · Received July 7, 2025

Report

Report Number
MW5172245
Event Type
Injury
Date Received
July 7, 2025
Date of Event
June 27, 2025
Report Date
June 28, 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

DEXCOM G7. THIS WILL BE THE 4TH UNIT I HAVE HAD TO REPORT TO DEXCOM. THE LAST 3 WERE FROM THE SAME LOT NUMBER AND THE ISSUE WAS DEXCOM SHOWING RADICAL LOW GLUCOSE LEVELS EVEN AFTER 48 HOURS OF WEAR (SPAN OF DIFFERENCE ~80 PTS). THE NEWEST FAILED G7 WAS AFTER 24 HOURS OF HAVING TO RECALIBRATE MULTIPLE TIMES AND AVERAGE DISCREPANCY OF >140. THIS PUT ME AT HIGH RISK IF DKA DURING SLEEP SINCE MY CLOSED LOOP SYSTEM PUMP DID NOT INCREASE MY INSULIN WHEN NEEDED THINKING I WAS TOO "LOW" IT SUSPENDED MY INSULIN WHILE I SLEPT. ON (B)(6) 2025 AT 10:05 AM PDT NEW G7 STATED BG WAS 57 WHILE BLOOD GLUCOMETER READING WAS 180. (RECALIBRATED G7) (B)(6) 2025 AT 2:00 PM PDT G7 STATED BLOOD GLUCOSE OF 84, GLUCOMETER 184 (RECALIBRATED AGAIN) (B)(6) 2025 AT 3:30 PM G7 = 66, GLUCOMETER 148 (RECALIBRATED) (B)(6) 2025 10:00 PM PDT G7 = 132, GLUCOMETER = 141, I THOUGHT G7 WAS FINALLY CALIBRATING PROPERLY AND WENT TO BED. (B)(6) 2025 AT 6AM PDT G7 STATED BG WAS 68 WHILE 3 SEPARATE GLUCOMETER READINGS WERE 259, 242 AND 233 RESPECTIVELY. (RECALIBRATED G7) (B)(6) 2025 G7 9:00 AM PDT STATED BG WAS 77 GLUCOMETERS READING 229. RISK OF DKA (DIABETIC KETOACIDOSIS). LARGE KETONES POSITIVE. (B)(6) 2025 CONTINUED FALSE G7 READINGS (7) WITH AVERAGE DISCREPANCY >120 POINTS. I PULLED THE G7, FOUND AN OLD G6 TRANSMITTER AND SENSOR AND PLACED IT. READINGS SPOT ON FROM START. I CALLED DEXCOM AND THEY ARE ONCE AGAIN SENDING ME A REPLACEMENT G7. I TOLD THEM THE LAST 3 WERE FROM SAME LOT NUMBER AND NOW THIS ONE IS FROM A NEW LOT NUMBER. I ASKED FOR A SUMMARY REPORT OF FINDINGS FROM ALL MY SUBMISSIONS OF MALFUNCTIONS G7S AND WAS TOLD I CANNOT SEE ANY REPORTS OF FINDINGS. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1051034 DEXCOM G7 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. 1825112005

Patients

Seq Age Sex Outcome Treatment
1 65 YR Female Other| L DAILY VITAMIN.| DEXILANT 60 MG QD QSYMIA.| QSYMIA.| T-SLIM TANDEM INSULIN PUMP.