N
Patient 1
(B)(4).
MAUDE MDR 9908333
- MDR report key
- 9908333
- Report number
- 3004753838-2020-031101
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-25
- 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 G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | DEXCOM, INC. | QBJ | 9500-45 | STS-OR-001 | 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 AT THE ABDOMEN ON (B)(6) 2020. NO PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.