FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2921132
·
Received January 17, 2013
Report
- Report Number
- 3004753838-2013-00016
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 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 THAT DAY, WIRE WAS MISSING FROM UNDERSIDE OF SENSOR POD. PATIENT WAS ABLE TO FEEL WIRE PROTRUDING FROM INSERTION SITE. PATIENT'S WIFE REMOVED WIRE FROM SKIN.AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTED SLIGHT ITCH AT SITE, BUT THAT HE IS IN FINE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26091 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 | 5042677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |