FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5820709
·
Received July 25, 2016
Report
- Report Number
- 3004753838-2016-50009
- Event Type
- Malfunction
- Date Received
- July 25, 2016
- Date of Event
- June 28, 2016
- Report Date
- June 28, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000095
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
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.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003 / SERIAL NUMBER (B)(4)/LOT NUMBER 5211632 ), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 07/20/2016. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF UNRECOVERABLE LOSS OF ANTENNA PASSED THRESHOLD WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472175 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-BLU | 5195791 | 00386270000095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |