FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7546682
·
Received May 25, 2018
Report
- Report Number
- 3004753838-2018-056584
- Event Type
- Malfunction
- Date Received
- May 25, 2018
- Date of Event
- April 27, 2018
- Report Date
- April 27, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 40386270000253
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE PRODUCT CODE: QBJ.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, 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) 2018. DATA WAS RECEIVED FOR EVALUATION, DATA REVIEW CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389369 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-45 | 5236575 | 40386270000253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |