FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5800438
·
Received July 16, 2016
Report
- Report Number
- 3004753838-2016-24567
- Event Type
- Malfunction
- Date Received
- July 16, 2016
- Date of Event
- June 22, 2016
- Report Date
- June 22, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000231
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE PATIENT'S RECEIVER DISPLAYED ERROR 121. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
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 DISPLAY WAS CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454281 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22719 | 5209919 | 00386270000231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |