FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 3714027
·
Received March 31, 2014
Report
- Report Number
- 3004753838-2014-18496
- Event Type
- Malfunction
- Date Received
- March 31, 2014
- Date of Event
- January 13, 2013
- Report Date
- April 16, 2013
- Manufacturer
- DEXCOM INC
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE RETURNED TRANSMITTER CONFIRMED THE PERMANENT OUT OF RANGE SIGNAL. A RECEIVER (SN (B)(4), MFG DATE: 12/10/2012) WAS ALSO RETURNED FOR EVALUATION AND THERE WAS NO ISSUE DETECTED.
Description of Event or Problem · 1
CONSUMER REPORTED PERMANENT OUT OF RANGE SIGNAL. THE CONSUMER DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189473 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS, PRODUCT CODE: MDS | MDS | DEXCOM INC | 9348-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |