BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1013970 · Received March 14, 2008

    Report

    Report Number
    2954730-2008-00130
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 14, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE UNK, INRATIO 1.8, LAB 2.1, MEAN 2.0, CONFIDENCE LIMITS 1.3 - 2.7. DATE: 2008, INRATIO 5.1, LAB 5.7, MEAN 5.4, CONFIDENCE LIMITS CANNOT BE DETERMINED. DATE: SAME DAY, INRATIO 3.7, LAB 5.1, MEAN 4.4, CONFIDENCE LIMITS 2.5 - 6.5. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. FOR THE 1ST AND 3RD DATA SET, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. FOR THE 2ND DATA SET, THE READINGS ARE CONSIDERED ACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. 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. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: NI. FIRST TEST INR = 1.1; SECOND TEST INR = 1.3. MEAN = 1.2; SD = 0.14; %CV = 11.8. THE %CV IS LESS THAN 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE UNK, INRATIO 1.8, LAB 2.1. DATE: 2008, INRATIO 5.1, LAB 5.7. DATE: SAME DAY, INRATIO 3.7, LAB 5.1. CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.1; SECOND TEST INR = 1.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ KIT, PROFESSIONAL USER, ENGLISH NI

    Patients

    Seq Age Sex Outcome Treatment
    1