FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2925842
·
Received January 22, 2013
Report
- Report Number
- 3004753838-2013-00022
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 27, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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) 2012 TO REPORT THAT UPON REMOVAL OF SENSOR ON (B)(6) 2012 DUE TO SENSOR ERROR, PATIENT BELIEVES A PORTION OF THE SENSOR WIRE REMAINED UNDER HER SKIN. PATIENT CONTACTED HER PHYSICIAN, BUT HAS NOT HEARD BACK. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BRUISING AND DISCOMFORT AT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29548 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5042476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |