FDA Adverse Event
Other
Summary report: N
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
MDR report key: 2445517
·
Received February 3, 2012
Report
- Report Number
- 3004753838-2012-00031
- Event Type
- Other
- Date Received
- February 3, 2012
- Date of Event
- January 6, 2012
- Report Date
- January 10, 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
INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, TO REPORT THAT UPON SENSOR REMOVAL, PT NOTICED THAT SENSOR WAS MISSING. NO SYMPTOMS ARE OBSERVED AT THE INSERTION SITE. UPON REQUEST FROM DEXCOM TECHNICAL SUPPORT, INTERNATIONAL DISTRIBUTOR HAS TRIED TO GATHER MORE INFO FROM PT BUT PT HAS BEEN INACCESSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR | MDS | DEXCOM, INC. | 9500-03 | 5032592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |