FDA Adverse Event
Malfunction
Summary report: N
STELO GLUCOSE BIOSENSOR SYSTEM
MDR report key: 21345436
·
Received February 10, 2025
Report
- Report Number
- 3004753838-2025-033873
- Event Type
- Malfunction
- Date Received
- February 10, 2025
- Date of Event
- January 20, 2025
- Report Date
- November 3, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- PMA / PMN Number
- K234070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4). MFR NO 3004753838-2025-033873 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 2/11/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT A BROKEN NEEDLE OR CANNULA OCCURRED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1514191 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1724187002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male |