FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7594448
·
Received June 12, 2018
Report
- Report Number
- 3004753838-2018-063861
- Event Type
- Malfunction
- Date Received
- June 12, 2018
- Date of Event
- May 12, 2018
- Report Date
- May 15, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- OBJ
- UDI-DI
- 00386270000804
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180515-001044
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED. A PROBABLE CAUSE WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
CROSS REFERENCES
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433048 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | OBJ | DEXCOM, INC. | N/A | 00386270000804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |