FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM
MDR report key: 5431323
·
Received February 11, 2016
Report
- Report Number
- 3004753838-2016-16270
- Event Type
- Malfunction
- Date Received
- February 11, 2016
- Date of Event
- January 18, 2016
- Report Date
- January 18, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000200
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 5202762), BEING USED WITH THE COMPLAINT RECEIVER WAS RETURNED ON 03/09/2016. THE RETURNED TRANSMITTER 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'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87343 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22608-BLU | 5205020 | 00386270000200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |