FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2854362
·
Received December 3, 2012
Report
- Report Number
- 3004753838-2012-00321
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Date of Event
- November 4, 2012
- Report Date
- November 4, 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 SAME DAY DUE TO SENSOR FAILURE, THE SENSOR WIRE WAS MISSING. SHE BELIEVES SHE CAN FEEL IT UNDER HER SKIN. NO PORTION OF THE WIRE IS VISIBLE. PATIENT REPORTS SLIGHT PAIN UPON TOUCHING THE INSERTION SITE. AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTS THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT SHE 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 | 5032604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |