N
Patient 1
(B)(4).
MAUDE MDR 9908466
- MDR report key
- 9908466
- Report number
- 3004753838-2020-031126
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-13
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS ASHLEY SPOTO
- Address
- 6340 SEQUENCE DR. SAN DIEGO CA 92121 US
- Phone
- 858-858-8582
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | DEXCOM, INC. | PQF | 9500-27 | STS-MC-004 | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2020. NO PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.