INRATIO
Received Jan 9, 2007 · Event occurred Dec 18, 2006
Report 2954730-2007-00016 · MDR key 810104
Device
Generic name
Prothrombin Time Test
Manufacturer
Hemosense, Inc.Model number
*Catalog number
*
Lot number
NI
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CALLER ALLEGED INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: INRATIO: 4.0, LAB: 2.9.
Additional Manufacturer Narrative
DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: IN 2006, INRATIO: 4.0, LAB: 2.9, MEAN: 3.5, CONFIDENCE LIMITS: 2.2-5.3. PER INTERNAL PROCEDURE, TR 0150M, 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. BASED ON MEDICAL ADVISOR REVIEW, MEDICATION WOULD HAVE CHANGED IF THE READING OF 4.0 WAS REPEATED FROM LAB.