BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 892151 · Received September 19, 2006

    Report

    Report Number
    2954730-2006-00502
    Event Type
    Malfunction
    Date Received
    September 19, 2006
    Date of Event
    September 15, 2006
    Report Date
    September 15, 2006
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060340: IN 2006= FIRST TEST INR: 4.0, SECOND TEST INR: 3.1, THIRD TEST INR: 3.0, MEAN= 3.4; SD=0.6; %CV=17.9%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060340: THE NEXT DAY= FIRST TEST INR: 3.8, SECOND TEST INR: 1.9, MEAN= 2.85; SD=1.3; %CV= 47%. THE %CV IS GREATER THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: IN 2006, INRATIO 4.1, LAB 3.89, MEAN 3.995, CONFIDENCE LIMITS 2.3 - 5.7, DATE: THE NEXT DAY, INRATIO 3.8, LAB 3.8, MEAN 3.8, CONFIDENCE LIMITS 2.3 - 5.7. PER INTERNAL PROCEDURE, 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 · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: IN 2006= FIRST TEST INR: 4.0, SECOND TEST INR: 3.1, THIRD TEST INR: 3.0. THE NEXT DAY= FIRST TEST INR: 3.8, SECOND TEST INR: 1.9. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: THE PREVIOUS DAY= INRATIO: 4.1, LAB:3.89; THE NEXT DAY= INRATIO: 3.8. LAB: 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060340

    Patients

    Seq Age Sex Outcome Treatment
    1 *