FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2509504
·
Received March 23, 2012
Report
- Report Number
- 3004753838-2012-00083
- Event Type
- Other
- Date Received
- March 23, 2012
- Date of Event
- March 6, 2012
- Report Date
- March 6, 2012
- 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, EVENT IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.
Description of Event or Problem · 1
PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR FAILURE, PT NOTICED THAT A SENSOR FRAGMENT HAD REMAINED INSERTED IN HIS SKIN. PT PROCEEDED TO REMOVE THE FRAGMENT WITH HIS OWN FINGERS. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS THAT THE INSERTION SITE LOOKED FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5037911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |