FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2026798
·
Received March 9, 2011
Report
- Report Number
- 3004753838-2011-00048
- Event Type
- Other
- Date Received
- March 9, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 14, 2011
- 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
DEXCOM'S DISTRIBUTOR CONTACT DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED A BROKEN SENSOR SHORTLY AFTER INSERTION. THE SENSOR WIRE BROKE UPON REMOVAL BUT COULD NOT BE SEEN UNDER PT'S SKIN. PT'S SKIN SHOWED SIGNS OF INFLAMMATION AT THE INSERTION SITE, SO PT'S PHYSICIAN SURGICALLY REMOVED THE SENSOR WIRE. PT WAS WELL AT THE TIME OF THE DISTRIBUTOR'S REPORT TO DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5012874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 MO | Other |