FDA Adverse Event
Injury
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2062624
·
Received April 8, 2011
Report
- Report Number
- 3004753838-2011-00088
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 14, 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 UNKNOWN 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
PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED SKIN IRRITATION (REDNESS DUE TO ITCHING) FROM HER SENSOR ADHESIVE. PATIENT CONSULTED HER ENDOCRINOLOGIST, WHO INDICATED THAT SHE HAD DEVELOPED AN ALLERGY TO THE SENSOR ADHESIVE. PATIENT WAS FINE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT AND REPORTED THAT SHE CONTINUES TO WEAR SENSORS.
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 | 63 YR | Other |