FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1021484
·
Received March 26, 2008
Report
- Report Number
- 2954730-2008-00143
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- February 27, 2008
- Report Date
- March 24, 2008
- Manufacturer
- HEMOSENSE, INC.
- Product Code
- JPA
- 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 TIME COMPLAINT WAS FILED: DATE - 2008, INRATIO - 1.1, LAB - 2.5, MEAN - 1.8, CONFIDENCE LIMITS - 1.3 - 2.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE INRATIO VALUE IS NO WITHIN THE CONFIDENCE LIMITS, BUT THE LAB VALUE IS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME.
Description of Event or Problem · 1
CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE - 2008, INRATIO - 1.1, LAB - 2.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE, INC. | BOXED STRIPS, 48 STRIPS, MULTIPA | 070510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |