FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6030536
·
Received October 14, 2016
Report
- Report Number
- 3004753838-2016-67236
- Event Type
- Malfunction
- Date Received
- October 14, 2016
- Date of Event
- September 25, 2016
- Report Date
- September 25, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THERE WERE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED AT THE ABDOMEN ON 09/25/2016. 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 |
|---|---|---|---|---|---|---|---|
| 680528 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | 9500-27 | ASKU | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | (B)(6) |