FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1791007
·
Received July 29, 2010
Report
- Report Number
- 2027969-2010-01087
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- July 6, 2010
- Report Date
- July 29, 2010
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER HAD DISCREPANT RESULTS: (B)(6) 2010: INRATIO: 3.2, (B)(6) 2010: INRATIO: 1.9
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | BIOSITE INCORPORATED | 100071 | 227900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |