FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2553064
·
Received April 25, 2012
Report
- Report Number
- 3004753838-2012-00109
- Event Type
- Other
- Date Received
- April 25, 2012
- Date of Event
- April 5, 2012
- Report Date
- April 6, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT A SENSOR WIRE FRAGMENT, SEEN AS A BLACK DOT FLUSH WITH SKIN, HAD REMAINED INSIDE PT'S SKIN AFTER SENSOR REMOVAL. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Other |