FDA Adverse Event
Injury
Summary report: N
INRATIO
MDR report key: 1020946
·
Received March 28, 2008
Report
- Report Number
- 2954730-2008-00152
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 27, 2008
- Manufacturer
- HEMOSENSE SJ
- Product Code
- JPA
- Adverse Event
- Yes
- 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: 2.3, LAB: 9.01, MEAN: 5.655, CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PER TEXT "PATIENT GIVEN VITAMIN K AND RELEASED FROM HOSPITAL." THIS IS ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED. PER TEXT "PATIENT HAS SINCE BEEN STABLE WITH NORMAL INR READINGS."
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 2.3, LAB: 9.01. PER TEXT "PATIENT GIVEN VITAMIN K AND RELEASED FROM HOSPITAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE SJ | 070510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |