FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3053505
·
Received April 11, 2013
Report
- Report Number
- 3004753838-2013-00092
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 15, 2013
- Manufacturer
- DEXCOM INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.
Description of Event or Problem · 1
INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2013 TO REPORT THAT ADULT PATIENT HAD EXPERIENCED 2 SENSOR FAILURES ON (B)(6) 2013. UPON SENSOR REMOVAL, SENSOR WAS MISSING, NOT TO BE FOUND IN HER SKIN OR ELSEWHERE. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED THAT SHE WAS FEELING FINE. THIS IS COMPLAINT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156155 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM INC. | 9500-27 | 5045894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |