FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5243935
·
Received November 23, 2015
Report
- Report Number
- 3004753838-2015-73414
- Event Type
- Malfunction
- Date Received
- November 23, 2015
- Date of Event
- October 30, 2015
- Report Date
- October 30, 2015
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000279
- 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). DESCRIBE EVENT OR PROBLEM, ADDITIONAL. ADDITIONAL INFORMATION/DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER, ADDITIONAL. EVENT PROBLEM AND EVALUATION CODES, ADDITIONAL.
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT THE RECEIVER DISPLAYED ERROR 146 ON (B)(6) 2015. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND SCREEN ERROR ALARMS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAYED WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773244 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22719-BLU | 5204525 | 00386270000279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |