FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5875046
·
Received August 15, 2016
Report
- Report Number
- 3004753838-2016-29262
- Event Type
- Malfunction
- Date Received
- August 15, 2016
- Date of Event
- June 29, 2016
- Report Date
- July 16, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
FOREIGN DISTRIBUTOR CONTACTED DEXCOM ON (B)(6) 2016, ON BEHALF OF HE PATIENT, 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
FOREIGN DISTRIBUTOR CONTACTED DEXCOM ON (B)(6) 2016, ON BEHALF OF HE PATIENT, TO REPORT A PERMANENT OUT OF RANGE SIGNAL THAT OCCURRED ON (B)(6) 2016. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE REPORTED EVENT OF UNRECOVERABLE LOSS OF ANTENNA PASSED THRESHOLD COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528398 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT20649-1 | 5040397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |