FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1112010
·
Received August 12, 2008
Report
- Report Number
- 2954730-2008-00496
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 16, 2008
- Report Date
- August 8, 2008
- Manufacturer
- HEMOSENSE, INC.
- Product Code
- JPA
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME THE COMPLAINT WAS FILED: DATE: 2008, INRATIO 2.6, LAB 3.7, MEAN 3.15, CONFIDENT LIMITS 1.9-4.6. THE INRATIO VALUE AND LAB VALUE ARE WITHIN THE CONFIDENT LIMIT. SO PER INTERNAL PROCEDURE, INVESTIGATION IS NOT NEEDED.
Description of Event or Problem · 1
THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008, INRATIO 2.6, LAB 3.7.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE, INC. | 0100004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |