FDA Adverse Event
Malfunction
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 2766037
·
Received October 1, 2012
Report
- Report Number
- 3004753838-2012-00271
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 7, 2012
- Report Date
- September 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 THE SAME DAY DUE TO FAILED SENSOR, THE WIRE WAS MISSING. AT THE TIME OF HIS CALL INTO TECHNICAL SUPPORT, PATIENT REPORTS 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 | 5039901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |