FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 5258002
·
Received December 1, 2015
Report
- Report Number
- 3004753838-2015-77606
- Event Type
- Malfunction
- Date Received
- December 1, 2015
- Date of Event
- November 6, 2015
- Report Date
- November 7, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE RETURNED TRANSMITTER (PART NUMBER STT-GL-003/LOT NUMBER 5200720), WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WASN'T RETURNED, BUT THE TRANSMITTER ( 6B4NA) THAT WAS USED WITH THE DEVICE HAS BEEN RECEIVED FOR EVALUATION ON (B)(6) 2015. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788450 | DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22495 | 5203294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |