FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1000777
·
Received February 19, 2008
Report
- Report Number
- 2954730-2008-00076
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 22, 2008
- Report Date
- February 19, 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 TIME COMPLAINT WAS FILED: DATE: 2007; INRATIO: >7.5; LAB: 1.7 (NEXT DAY); MEAN: NA; CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE TIME INTERVAL BETWEEN TESTS WAS DONE GREATER THAN 3 HOURS. THE COMPARISON WAS CONSIDERED INVALID. PRODUCTS WILL BE TESTED WHEN RETURNED.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: >7.5; LAB: 1.7 (NEXT DAY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE SJ | 070308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |