FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2105329
·
Received May 2, 2011
Report
- Report Number
- 3004753838-2011-00116
- Event Type
- Other
- Date Received
- May 2, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 6, 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
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED A BROKEN SENSOR WIRE. UPON REMOVING THE SENSOR, SHE NOTICED THAT PART OF THE SENSOR WIRE WAS PROTRUDING FROM HER SKIN. PATIENT REMOVED THE WIRE WITH HER FINGER AND AN ALCOHOL WIPE. PATIENT REPORTED EXPERIENCING SOME DISCOMFORT FOR A FEW DAYS BUT WAS FINE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT.
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 | 50 YR | Other |