FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3782333
·
Received April 30, 2014
Report
- Report Number
- 3004753838-2014-06907
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 8, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION OF THE RETURNED RECEIVER AND REVIEW OF THE DATA LOG CONFIRMED THE REPORTED OUT OF RANGE SIGNAL. ADDITIONALLY, A TRANSMITTER (PART NUMBER: 9438-01; SERIAL NUMBER (B)(4)) WAS RETURNED AND EVALUATED. THERE WERE NO DEFECTS FOUND WITH THE TRANSMITTER.
Description of Event or Problem · 1
DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN OUT OF RANGE SIGNAL ON (B)(6) 2014. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259941 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649 | 5086029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |