STELO GLUCOSE BIOSENSOR SYSTEM
Report
- Report Number
- 3004753838-2025-170143
- Event Type
- Malfunction
- Date Received
- July 2, 2025
- Date of Event
- June 9, 2025
- Report Date
- October 15, 2025
- Manufacturer
- DEXCOM, INC.
- Product Code
- SAF
- UDI-DI
- 00386270004345
- PMA / PMN Number
- K234070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 3004753838-2025-170143 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.
(B)(4).
(B)(4). B5 DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D4 MODEL NO - ADDITIONAL INFORMATION. D4 LOT NO - ADDITIONAL INFORMATION. PRIMARY UDI NUMBER - ADDITIONAL INFORMATION. H4 DEVICE MFG DATE - ADDITIONAL INFORMATION. H2 TYPE OF FOLLOW UP - ADDITIONAL INFORMATION. H6 TYPE OF INVESTIGATION - ADDITIONAL INFORMATION.
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 6/23/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
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. 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 |
|---|---|---|---|---|---|---|---|
| 6934 | STELO GLUCOSE BIOSENSOR SYSTEM | CONTINUOUS GLUCOSE MONITOR | SAF | DEXCOM, INC. | 9500-174 | 1725110005 | 00386270004345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Unknown |