FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1130006
·
Received August 19, 2008
Report
- Report Number
- 2954730-2008-00502
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- July 21, 2008
- Report Date
- August 11, 2008
- Manufacturer
- HEMOSENSE, INC.
- Product Code
- JPA
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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 3.6, LAB 1.9, MEAN 2.75, CONFIDENT LIMITS 1.7-3.8. AS PER INTERNAL PROCEDURE, (REV.2) IF INRATIO AND LAB VALUE ARE WITHIN CONFIDENT LIMIT, NO INVESTIGATION IS NEEDED. ALSO THE CALLER SELF TESTING (NOT THE USER) AND READING WAS 1.0. THIS READING WILL NOT BE TAKEN INTO CONSIDERATION FOR CALCULATING THE CONFIDENCE LIMIT SINCE IT IS FROM TWO DIFFERENT PERSON.
Description of Event or Problem · 1
THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO 3.6; LAB 1.9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE, INC. | 0100004 | NP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |