FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 5609075
·
Received April 26, 2016
Report
- Report Number
- 3004753838-2016-18803
- Event Type
- Malfunction
- Date Received
- April 26, 2016
- Date of Event
- April 4, 2016
- Report Date
- April 4, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000156
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003 SERIAL NUMBER (B)(4)/LOT NUMBER 5203728), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(6) 2016. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT A PERMANENT OUT OF RANGE SIGNAL THAT OCCURRED ON (B)(6) 2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262930 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22495 | 5206616 | 00386270000156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |