FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2822396
·
Received November 7, 2012
Report
- Report Number
- 3004753838-2012-00300
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 11, 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 AFTER REMOVAL OF SENSOR ON (B)(6) 2012 DUE TO SENSOR FAILURE, THE WIRE WAS MISSING FROM UNDERSIDE OF SENSOR POD. PATIENT BELIEVES HE WAS ABLE TO FEEL SOMETHING UNDER HIS SKIN AFTER SENSOR REMOVAL. NO PORTION OF THE WIRE IS VISIBLE AT THE INSERTION SITE. AT THE TIME OF HIS CALL TO TECHNICAL SUPPORT, PATIENT REPORTS NO DISCOMFORT AND THAT HE IS IN FINE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9500-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |