FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 14286289
·
Received May 5, 2022
Report
- Report Number
- 3004753838-2022-071652
- Event Type
- Malfunction
- Date Received
- May 5, 2022
- Date of Event
- April 4, 2022
- Report Date
- July 22, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4)
Description of Event or Problem · 0
IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, AFTER FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE TRANSMITTER FAILED/ERROR/ALERT. REPORT WAS SUBMITTED IN ERROR. PLEASE DISREGARD ALL INFORMATION IN MFR 3004753838-2022-071652 AS THIS WILL NOT BE REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1564824 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | 5293736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |