FDA Adverse Event
Malfunction
Summary report: N
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 4240834
·
Received November 10, 2014
Report
- Report Number
- 3004753838-2014-31679
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- August 26, 2014
- Report Date
- October 13, 2014
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 ON PATIENT'S BEHALF TO REPORT PERMANENT OUT OF RANGE ON (B)(6) 2014. AT THE TIME OF CONTACT THE FOREIGN DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Description of Event or Problem · 1
THE COMPLAINT TRANSMITTER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT UNRECOVERABLE LOSS OF ANTENNA PASSED THRESHOLD WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722210 | G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | 9438-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |