FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5496520
·
Received March 11, 2016
Report
- Report Number
- 3004753838-2016-33618
- Event Type
- Malfunction
- Date Received
- March 11, 2016
- Date of Event
- February 17, 2016
- Report Date
- February 17, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000231
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CLINICAL RESEARCH COORDINATOR CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT THE RECEIVER DISPLAYED ERROR 171 ON (B)(6) /2016. THE CLINICAL RESEARCH COORDINATOR DID NOT 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.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE DATA LOG WAS REVIEWED AND SCREEN ERROR ALARMS AND FIRMWARE ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151725 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22719 | 5206630 | 00386270000231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |