INRATIO
Received Jan 9, 2007 · Event occurred Dec 18, 2006
Report 2954730-2007-00010 · MDR key 810140
Device
Generic name
Prothrombin Time Test
Manufacturer
Hemosense, Inc.Model number
*Catalog number
*
Lot number
060452
Product problems
- Imprecision
- 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 IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 3.7, SECOND TEST INR = 5.3. FIRST TEST INR = 3.7, THIRD TEST INR = 4.4. CALLER ALLEGED INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 12/18/2006, INRATIO: 5.80, LAB: 4.64, MEAN: 5.22, CONFIDENCE LIMITS: UNABLE TO BE DETERMINED. DATE: 12/18/2006, INRATIO 3.70, LAB: 4.40, MEAN: 3.90, CONFIDENCE LIMITS: 2.3 - 5.7.
Additional Manufacturer Narrative
INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060452: FIRST TEST INR = 3.7, SECOND TEST INR = 5.3, MEAN = 4.5; SD = 1.13; %CV = 25.1%. THE %CV IS GREATER THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BE END-USER LOT 060452: FIRST TEST INR = 3.7, THIRD TEST INR = 4.4, MEAN = 4.05; SD = 0.49; %CV = 12.2%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, TR 0150, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.