FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2210083
·
Received August 2, 2011
Report
- Report Number
- 3004753838-2011-00226
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- July 3, 2011
- Report Date
- July 5, 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
PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT A WIRE WAS PROTRUDING FROM HIS SKIN UPON REMOVAL OF SENSOR DUE TO A SENSOR FAILURE ONE HR AFTER SESSION STARTUP. PT WAS ABLE TO PULL OUT BROKEN SENSOR FROM HIS SKIN WITH TWEEZERS. PT FELT NO DISCOMFORT AT INSERTION SITE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. DURING HIS CALL TO DEXCOM TECHNICAL SUPPORT PT REPORTS FEELING 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 | 61 YR | Other |