FDA Adverse Event
Malfunction
Summary report: N
3030677-2018-02479
MDR report key: 8038848
·
Received November 5, 2018
Report
- Report Number
- 3030677-2018-02479
- Event Type
- Malfunction
- Date Received
- November 5, 2018
- Report Date
- October 10, 2018
- PMA / PMN Number
- 020715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS CASE WAS PREVIOUSLY REPORTED ON PR 8780453 WITH MDR #3030677-2018-02661. THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |