FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
MDR report key: 5419208
·
Received February 9, 2016
Report
- Report Number
- 3004753838-2016-00884
- Event Type
- Malfunction
- Date Received
- February 9, 2016
- Date of Event
- January 14, 2016
- Report Date
- January 14, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000194
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT THAT ON (B)(6) 2016, THE PATIENT'S RECEIVER WAS OVERHEATING. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A REVIEW OF THE DOWNLOADED DATA LOG FOUND A ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE RECEIVER CASE WAS OPENED FOR FURTHER EVALUATION. NO DEFECTS WERE FOUND DURING AN INTERIOR INSPECTION. THE REPORTED EVENT OF AN OVERHEATING RECEIVER WAS CONFIRMED THROUGH LGO REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78267 | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM | MDS | MDS | DEXCOM, INC. | MT22608-PNK | 5198378 | 00386270000194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |