FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2582813
·
Received May 16, 2012
Report
- Report Number
- 3004753838-2012-00131
- Event Type
- Other
- Date Received
- May 16, 2012
- Date of Event
- April 17, 2012
- Report Date
- April 17, 2012
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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
DIABETES CENTER REPRESENTATIVE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2012 TO REPORT THAT SENSOR WIRE HAD BROKEN INSIDE PATIENT'S SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, DIABETES CENTER REPRESENTATIVE REPORTED THAT PATIENT APPEARED TO BE DOING FINE AND THAT NO MEDICAL INTERVENTION WAS SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5030012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |