FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 11626809
·
Received April 7, 2021
Report
- Report Number
- 3004753838-2021-64181
- Event Type
- Malfunction
- Date Received
- April 7, 2021
- Date of Event
- March 13, 2021
- Report Date
- May 7, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- QDK
- UDI-DI
- 00386270000255
- PMA / PMN Number
- K182041
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, A ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SENSOR WAS PRODUCING SHOCK. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2021. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524896 | DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QDK | DEXCOM, INC. | 9438-06 | NI | 00386270000255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |