FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1812746
·
Received August 16, 2010
Report
- Report Number
- 2027969-2010-01213
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- July 22, 2010
- Report Date
- August 16, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
PT SELF TESTER REPORTED DISCREPANT RESULTS: (B)(6) 2010, INRATIO: 2.1; (B)(6) 10, INRATIO: 3.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 225324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |