FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7421452
·
Received April 11, 2018
Report
- Report Number
- 3004753838-2018-038007
- Event Type
- Malfunction
- Date Received
- April 11, 2018
- Date of Event
- April 8, 2018
- Report Date
- September 28, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000002
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
COM-(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 A LOSS OF CONNECTION HAD OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION HOWEVER DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 04/08/2018, THAT ON 04/08/2018, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264341 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | N/A | 00386270000002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |