FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2625780
·
Received June 14, 2012
Report
- Report Number
- 3004753838-2012-00162
- Event Type
- Other
- Date Received
- June 14, 2012
- Date of Event
- May 15, 2012
- Report Date
- May 16, 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 WAS A REPORTABLE EVENT, EVEN 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 AN EARLY SENSOR SHUTOFF, PT NOTICED THAT SENSOR WIRE HAD REMAINED INSIDE HIS SKIN. PT PROCEEDED TO PULLING IT OUT OF HIS SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTED THAT HE WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |