FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2326641
·
Received October 14, 2011
Report
- Report Number
- 3004753838-2011-00297
- Event Type
- Other
- Date Received
- October 14, 2011
- Date of Event
- September 17, 2011
- Report Date
- September 20, 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
INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT UPON REMOVAL OF SENSOR DUE TO EARLY SENSOR ERROR, PATIENT NOTICED THAT SENSOR WAS MISSING. PATIENT BELIEVES THAT IT IS UNLIKELY THAT A BROKEN SENSOR IS INSIDE HIS SKIN. PATIENT DID NOT SEEK MEDICAL INTERVENTION NOR FEELS ANY DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5016842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |