BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1013964 · Received March 14, 2008

    Report

    Report Number
    2954730-2008-00133
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 14, 2000
    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: 2008, INRATIO 5.0, LAB 5.2, MEAN 5.1, CONFIDENCE LIMITS CANNOT BE DETERMINED. DATE: SAME DAY, INRATIO 3.3, LAB 5.2, MEAN 4.25, CONFIDENCE LIMITS: 2.4-6.1. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR DATE SET # 1, THE READINGS ARE CONSIDERED ACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. FOR DATA SET # 2, 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 ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008, INRATIO: 5.0, LAB: 5.2; DATE: SAME DAY, INRATIO: 3.3, LAB: 5.2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1