FDA Adverse Event
Malfunction
Summary report: N
STELO GLUCOSE BIOSENSOR SYSTEM
MDR report key: 21996853
·
Received May 9, 2025
Report
- Report Number
- 3004753838-2025-113311
- Event Type
- Malfunction
- Date Received
- May 9, 2025
- Date of Event
- April 11, 2025
- Report Date
- October 30, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- UDI-DI
- 00386270004338
- PMA / PMN Number
- K234070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). E1 INITIAL REPORTER EMAIL ADDRESS: (B)(6).
Additional Manufacturer Narrative · 0
(B)(4). 3004753838-2025-113311 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 DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE BACK OF UPPER ARM ON (B)(6) 2025. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 4/22/2025. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1217454 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1725045001 | 00386270004338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |