FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2921118
·
Received January 17, 2013
Report
- Report Number
- 3004753838-2013-00017
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 21, 2012
- Report Date
- December 21, 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 ON DATE OF REPORT THE SENSOR POD AND TRANSMITTER JOINTLY BECOME DISLODGED FROM THE SENSOR ON HIS BODY. PATIENT REPORTED THAT THE ADHESIVE REMAINED ON APPLICATION SITE AND SENSOR WIRE REMAINED PROTRUDING FROM HIS SKIN. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED THAT HE IS IN FINE CONDITION. NO MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26700 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5044222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |