FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6113694
·
Received November 18, 2016
Report
- Report Number
- 3004753838-2016-29956
- Event Type
- Malfunction
- Date Received
- November 18, 2016
- Date of Event
- October 24, 2016
- Report Date
- October 29, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 10/29/2016 THAT ON (B)(6) 2016, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG CONFIRMED THE REPORTED INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763570 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9500-27 | 5215263 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | UNKNOWN SMART DEVICE |