INRATIO
Received Jan 19, 2007 · Event occurred Jan 12, 2007
Report 2954730-2007-00032 · MDR key 807738
Device
Generic name
Prothrombin Time Test
Manufacturer
Hemosense, Inc.Model number
*Catalog number
*
Lot number
060667
Product problems
- Low Readings
Patient
*
- Bleeding
Narrative
Description of Event or Problem
CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE 01/12/07, INRATIO 3.4, LAB 5.8; INRATIO 1.7 (12/29/06), LAB 5.8 (01/05/07). DOSE WAS CHANGED BASED ON INRATIO RESULT AND LATER PATIENT DEVELOPED NOSEBLEED.
Additional Manufacturer Narrative
DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE 01/12/07, INRATIO 3.4, LAB 5.8, MEAN 4.6, CONFIDENCE LIMITS 2.6-6.9; INRATIO 1.7 (12/29/06), LAB 5.8 (01/05/07), MEAN 3.75, CONFIDENCE LIMITS 2.2-5.3. PER INTERNAL PROCEDURE THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATE, 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. FOR THE SECOND SET OF DATA, THE TIME INTERVAL BETWEEN TESTS WAS > 3 HOURS. THE COMPARISON WAS CONSIDERED INVALID. THIS IS AN ADVERSE EVENT CASE. PRODUCTS WILL BE TESTED WHEN RETURNED.