N
Patient 1
(B)(4).
MAUDE MDR 9908624
- MDR report key
- 9908624
- Report number
- 3004753838-2020-030666
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-09
- 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 | N/A | SW11677 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. PER DOC (B)(4), CASES WHERE THE SENSOR SESSION LINE IS MISSING IN SHARE SUPPORT TOOL AND SHARE SUPPORT SERVICE, COMPLAINTS WILL BE CLOSED SINCE A DATA INVESTIGATION CANNOT BE COMPLETED AS DATA AMBIGUITY CANNOT BE RESOLVED FURTHER. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.