FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1021488
·
Received March 26, 2008
Report
- Report Number
- 2954730-2008-00142
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 24, 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. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR ALL 4 DATA SETS, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED 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 INRATIO. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 2.6, 2.5, 3.4, 2.6; LAB: 3.47, 5.69, 4.48, 5.52.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE SJ, | KIT, PROFESSIONAL USER, ENGLISH | 070381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |