FDA Adverse Event
Injury
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 1994409
·
Received February 8, 2011
Report
- Report Number
- 3004753838-2011-00027
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 11, 2011
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P050012
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE HAD AN INFECTION AT HIS SENSOR INSERTION SITE. PT SAW A PHYSICIAN. PT'S PHYSICIAN LANCED THE INFECTED SITE AND PRESCRIBED ANTIBIOTICS. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTED THAT A KNOT WAS STILL PRESENT UNDER HIS SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |