FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3842368
·
Received June 1, 2014
Report
- Report Number
- 3004753838-2014-05635
- Event Type
- Malfunction
- Date Received
- June 1, 2014
- Date of Event
- August 5, 2013
- Report Date
- May 5, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT A PATIENT HAD CONTACTED THE DISTRIBUTOR AND CLAIMED THAT UPON REMOVAL OF THE SENSOR, PATIENT WAS UNABLE TO LOCATE THE SENSOR WIRE ON (B)(6) 2013. PATIENT DID NOT REPORT ANY DISCOMFORT AT INSERTION SITE. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320747 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE: MDS | MDS | DEXCOM, INC. | 9500-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |