N
Patient 1
(B)(4).
MAUDE MDR 9807777
- MDR report key
- 9807777
- Report number
- 3004753838-2020-023081
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-17
- Date received
- 2020-03-09
- 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 | CONTINUOUS GLUCOSE MONITOR | DEXCOM, INC. | MDS | MT24078-1 | STR-GS-004 | 5249827 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-09 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.