FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2509531
·
Received March 23, 2012
Report
- Report Number
- 3004753838-2012-00074
- Event Type
- Other
- Date Received
- March 23, 2012
- Date of Event
- February 27, 2012
- Report Date
- February 27, 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, EVEN IN THE ABSENCES 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 EARLY SENSOR FAILURE, PT FOUND THAT SENSOR HAD REMAINED INSERTED IN HIS ABDOMEN. PT'S WIFE PROCEEDED TO PULL OUT SENSOR WIRE FROM PT'S ABDOMEN USING TWEEZERS. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT'S FATHER REPORTS THAT PT WAS FEELING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5016841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |