FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2181526
·
Received July 14, 2011
Report
- Report Number
- 3004753838-2011-00217
- Event Type
- Other
- Date Received
- July 14, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 21, 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
INT'L DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT A PT NOTICED SOME BLOOD ON HIS SHIRT AND UPON SENSOR REMOVAL, PT NOTED THAT SENSOR WIRE WAS MISSING. PT BELIEVES THAT BROKEN SENSOR WIRE IS STILL INSIDE HIS SKIN. PT HAS NOT SOUGHT MEDICAL INTERVENTION BUT INSERTION SITE IS BRUISED, ITCHY AND INFLAMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5014361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |