FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 5160498
·
Received October 20, 2015
Report
- Report Number
- 3004753838-2015-72408
- Event Type
- Malfunction
- Date Received
- October 20, 2015
- Date of Event
- August 4, 2015
- Report Date
- September 23, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 TECHNICAL SUPPORT ON (B)(6) 2015 TO CLAIM INTERMITTENT VIBRATION ON (B)(6) 2015. AT THE TIME OF CONTACT THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. A REVIEW FO THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE COMPLAINT OF AN INTERMITTENT VIBRATION COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692410 | DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22495-PNK | 5202019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |