INRATIO
Received Sep 8, 2006 · Event occurred Sep 1, 2006
Report 2954730-2006-00488 · MDR key 885397
Device
Generic name
Prothrombin Time Test
Manufacturer
Hemosense, Inc.Model number
*Catalog number
*
Lot number
060043
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2006; PT#1; INRATIO: 2.0; LAB: 2.1; MEAN: 2.05; CONFIDENCE LIMITS: 1.4-3.1. 2006; PT#2; INRATIO: 2.1; LAB: 1.6; MEAN: 1.85; CONFIDENCE LIMITS: 1.3-2.7. 2006; PT#3; INRATIO: 2.8; LAB: 2.3; MEAN: 2.55; CONFIDENCE LIMITS: 1.7-3.8. 2006; PT#4; INRATIO: 1.9; LAB: 1.7; MEAN: 1.8; CONFIDENCE LIMITS: 1.3-2.7. 2006; PT#5; INRATIO: 2.1; LAB: 1.8; MEAN: 1.95; CONFIDENCE LIMITS: 1.3-2.7. PER INTERNAL PROCEDURE, TR, 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 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
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS. DATE: 2006; PT#1; INRATIO: 2.0; LAB: 2.1. 2006: PT#2; INRATIO: 2.1; LAB: 1.6. 2006; PT#3; INRATIO: 2.8; LAB: 2.3. 2006; PT#4; INRATIO: 1.9; LAB:1.7. 2006; PT#5; INRATIO: 2.1; LAB: 1.8.