FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7986683
·
Received October 19, 2018
Report
- Report Number
- 3004753838-2018-125687
- Event Type
- Malfunction
- Date Received
- October 19, 2018
- Date of Event
- September 23, 2018
- Report Date
- February 10, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- UDI-DI
- 00386270000255
- PMA / PMN Number
- P170031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PT REPORTING INACCURATE CGM VALUES REF: OSC 180926-002858, REF: OSC 180925-001797, REF: OSC 180925-001622.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 09/25/2018 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, BUT THE COMPLAINT CONFIRMATION AND 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 |
|---|---|---|---|---|---|---|---|
| 827255 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-45 | 5240014 | 00386270000255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |