FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 6030198
·
Received October 14, 2016
Report
- Report Number
- 3004753838-2016-72615
- Event Type
- Malfunction
- Date Received
- October 14, 2016
- Date of Event
- September 23, 2016
- Report Date
- September 23, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000156
- 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
THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. EXTERNAL VISUAL INSPECTION FOUND NO OBSERVATIONS RELATED TO THE CUSTOMER COMPLAINT. THE RECEIVER WILL NOT CHARGE OR TURN ON. THE REPORTED EVENT OF AN INITIALIZING SCREEN WITHOUT A MANUAL RESTART WAS NOT CONFIRMED. A ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE U5.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART ON (B)(6) 2016. THERE WAS NO REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681295 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22495 | 5211979 | 00386270000156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |