FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2924107
·
Received January 22, 2013
Report
- Report Number
- 3004753838-2013-00021
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 23, 2012
- Report Date
- December 24, 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 TRANSMISSION ISSUES, A PORTION OF THE SENSOR WIRE REMAINED PROTRUDING FROM HIS SKIN AT INSERTION SITE. PATIENT REMOVED THE WIRE FROM HIS SKIN. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED SLIGHT IRRITATION AT THE INSERTION SITE, AND PAIN ON OCCASION, BUT THAT HE IS IN FINE CONDITION. NO MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30140 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5039897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |