FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5142291
·
Received October 10, 2015
Report
- Report Number
- 3004753838-2015-81512
- Event Type
- Malfunction
- Date Received
- October 10, 2015
- Date of Event
- September 12, 2015
- Report Date
- September 13, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON 09/13/2015, ON BEHALF OF HER HUSBAND WHO IS A SEVEN DAY TRIAL PATIENT TO REPORT THAT ON (B)(6) 2015, UPON REMOVING THE SENSOR POD FROM THE PATIENT'S BODY THE SENSOR WIRE WAS MISSING. THE SENSOR WIRE WAS NOT FOUND AT THE INSERTION SITE OR ON THE SENSOR POD. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2015. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673830 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-27 | ASKU | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |