FDA Adverse Event
Malfunction
Summary report: N
8013649
MDR report key: 8013649
·
Received October 29, 2018
Report
- Report Number
- 8013649
- Event Type
- Malfunction
- Date Received
- October 29, 2018
- Date of Event
- October 8, 2018
- Report Date
- October 16, 2018
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 0
HOME INR MONITOR COMPARISON: PATIENT'S HOME MONITOR CHECKED IN THE CLINIC READ 2.8. THE LAB VALUE CHECKED THE SAME DAY SAID 2.5
Description of Event or Problem · 1
HOME INR MONITOR COMPARISON: PATIENT'S HOME MONITOR CHECKED IN THE CLINIC READ 2.8. THE LAB VALUE CHECKED THE SAME DAY SAID 2.5.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20440 DA |