FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1013971
·
Received March 14, 2008
Report
- Report Number
- 2954730-2008-00131
- Event Type
- Malfunction
- Date Received
- March 14, 2008
- Date of Event
- February 20, 2008
- Report Date
- March 14, 2008
- Manufacturer
- HEMOSENSE SJ
- 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 THE TIME COMPLAINT WAS FILED. DATE: 2008, INRATIO: 1.4, LAB: 2.1, MEAN: 1.75, CONFIDENCE LIMITS: 1.2-2.3. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED NOT DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME.
Description of Event or Problem · 1
CALLER ALLEGES INACCURACY WITH INRAIO. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 1.4, LAB: 2.1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE SJ | KIT, PROFESSIONAL USER, ENGLISH | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |