FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2593866
·
Received May 25, 2012
Report
- Report Number
- 3004753838-2012-00146
- Event Type
- Other
- Date Received
- May 25, 2012
- Date of Event
- April 30, 2012
- Report Date
- April 30, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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
PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, TO REPORT THAT UPON SENSOR REMOVAL DUE TO AN INTERRUPTION IN SENSOR READINGS, PT COULDN'T LOCATE THE SENSOR WIRE AND IS CONCERNED THAT SENSOR MAY BE INSIDE OF HER SKIN. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, BESIDES REDNESS AND TENDERNESS AROUND THE INSERTION SITE, PT REPORTS THAT SHE WAS FEELING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5029987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |