FDA Adverse Event
Malfunction
Summary report: N
STELO GLUCOSE BIOSENSOR SYSTEM
MDR report key: 24731870
·
Received March 30, 2026
Report
- Report Number
- 3004753838-2026-122290
- Event Type
- Malfunction
- Date Received
- March 30, 2026
- Date of Event
- March 13, 2026
- Report Date
- April 17, 2026
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- UDI-DI
- 00386270004345
- PMA / PMN Number
- K234070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4)
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2026-122290 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A BROKEN OR DETACHED WIRE OCCURRED. THE SENSOR WAS INSERTED ON (B)(6) 2026. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 4/13/2026 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794843 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1725119003 | 00386270004345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Male |