FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8143184
·
Received December 7, 2018
Report
- Report Number
- 3004753838-2018-153169
- Event Type
- Malfunction
- Date Received
- December 7, 2018
- Date of Event
- November 7, 2018
- Report Date
- November 8, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 AT THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE REPORTED INACCURACY COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE BASED ON CONFIRMATION THAT AN INACCURACY DID NOT OCCUR. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-153169.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 981602 | DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9500-46 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |