DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3004753838-2026-086733
- Event Type
- Injury
- Date Received
- February 9, 2026
- Date of Event
- January 12, 2026
- Report Date
- February 12, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270001870
- PMA / PMN Number
- K213919
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(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 HYPOGLYCEMIA. H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE: 4591 DECREASED LEVEL OF CONSCIOUSNESS/CODE NOT AVAILABLE H6 CODES: HEALTH EFFECT - CLINICAL CODE PROBLEM CODE : CORRECTION TO DISREGARD 4581 APPROPRIATE TERM/CODE NOT AVAILABLE.
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED ON 02/09/2026. IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. DATA WAS FURTHER REVIEWED AND FOUND IN CONNECTION WITH THE REPORTED ALLEGATION THAT ON THE ALLEGED INCIDENT DATE, (B)(6) 2026, STARTING AT 08:51 AM, THE APP DELIVERED URGENT LOW SOON ALERTS AT 90% VOLUME, WITH THE EGVS DROPPING BELOW THE LOW THRESHOLD (70 MG/DL) AT 08:56 AM, AND ALERTS CONTINUED UNTIL 09:06 AM. THE EGVS DROPPED BELOW THE URGENT LOW THRESHOLD (55 MG/DL), AND THE APP DELIVERED URGENT LOW ALERTS AT 90% VOLUME AT 09:11 AM AND 09:16 AM, THEN ESCALATED TO 100% VOLUME FROM 09:21 AM UNTIL THE URGENT LOW ALERT WAS ACKNOWLEDGED AT 09:51 AM. DURING THE FIXED, 30-MINUTE SNOOZE DURATION FOR THE URGENT LOW ALERT, EGVS ROSE FROM 66 MG/DL TO 85 MG/DL, THEN DROPPED DOWN TO 56 MG/DL. AT 10:26 AM AND 10:31 AM, THE APP DELIVERED URGENT LOW ALERTS AT 90% VOLUME, WHICH WAS ACKNOWLEDGED AT 10:32 AM. DURING THE FIXED, 30-MINUTE SNOOZE DURATION FOR THE URGENT LOW ALERT, EGVS REMAINED BELOW THE URGENT LOW THRESHOLD FOR 20 MINUTES, RISING TO 57 MG/DL AT 11:01 AM AND 71 MG/DL (BACK IN RANGE) AT 11:06 AM. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PATIENT EXPERIENCED A FAILURE TO ALERT, FOLLOWED BY A HYPOGLYCEMIC EVENT. ON (B)(6) 2026, WHILE ASLEEP, THE PATIENT HAD A HYPOGLYCEMIC EPISODE DURING WHICH NEITHER THE DEXCOM DISPLAY DEVICE NOR THE INSULIN PUMP PROVIDED AN ALERT. THE EXACT CGM VALUE AT THE TIME WAS UNKNOWN, THOUGH IT WAS PRESUMED TO BE LOW. NO FINGERSTICK MEASUREMENT WAS TAKEN BY THE PATIENT OR FAMILY MEMBERS. DURING THE EVENT, THE PATIENT WAS NOTED TO BE ¿TALKING FUNNY,¿ WITH EYES OPEN BUT APPEARING DISTANT. A FAMILY MEMBER ATTEMPTED TO GIVE THE PATIENT FOOD AND CONTACTED EMERGENCY SERVICES. THE REPORTER WAS UNSURE OF THE FINGERSTICK RESULT OBTAINED BY PARAMEDICS, AND NO CGM READINGS WERE DOCUMENTED AT THAT TIME. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE. NO ADDITIONAL MEDICATIONS WERE ADMINISTERED. THE PARAMEDICS REMAINED ON SITE FOR APPROXIMATELY 45 MINUTES, AND THE PATIENT DID NOT REQUIRE TRANSPORT TO THE HOSPITAL. THERE WAS NO FURTHER MEDICAL EVALUATION OR FOLLOW-UP INTERVENTION REPORTED. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE AND FEELING FINE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350947 | DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 00386270001870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Other | NON- INTEGRATED PUMP |