FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2326642
·
Received October 14, 2011
Report
- Report Number
- 3004753838-2011-00292
- Event Type
- Other
- Date Received
- October 14, 2011
- Date of Event
- September 16, 2011
- Report Date
- September 16, 2011
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR FAILURE AND SENSOR DEPLOYMENT ISSUES, SENSOR WAS PROTRUDING FROM HER SKIN. PATIENT WAS ABLE TO PULL SENSOR OUT OF HER SKIN WITH TWEEZERS. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTS FEELING FINE AND NOT EXPERIENCING ANY ADDITIONAL DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5015598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |