INRATIO
Received Sep 8, 2006 · Event occurred Sep 6, 2006
Report 2954730-2006-00491 · MDR key 759522
Device
Generic name
Prothromin Time Test
Manufacturer
Hemosense, Inc.Model number
*Catalog number
*
Lot number
060218
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
- Hospitalization required
Narrative
Description of Event or Problem
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 2006, INRATIO 2.1(THU) 1.5, LAB 8.0(FRI) 1.9 PATIENT WAS HOSPITALIZED.
Additional Manufacturer Narrative
DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END USER AT TIME COMPLAINT WAS FILED: DATE 2006, INRATIO 2.10THU) 1.5, LAB 8.0 (FRI) 1.9, MEAN 5.05 1.7, CONFIDENCE LIMITS CANNOT BE DETERMINED 1.2-2.3. PER INTERNAL PROCEDURE, TR, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. THE TIME INTERVAL BETWEEN TWO INRATIO AND LAB TEST WAS >3HOURS. PER TR, THE COMPARISON CONSIDERED INVALID. FOR THE SECOND SET OF DATA, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. PER TR, THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THIS IS AN ADVERSE EVENT CASE. PRODUCT WILL BE TESTED WHEN RETURNED.