FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2895360
·
Received January 3, 2013
Report
- Report Number
- 3004753838-2013-00004
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 7, 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, THE WIRE WAS VISIBLE PROTRUDING FROM HER SKIN AT THE SENSOR INSERTION SITE. PATIENT REMOVED THE WIRE FROM HER SKIN. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED A SLIGHT BRUISE, BUT THAT SHE IS IN FINE CONDITION. NO MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2511 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5045883 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other |