BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1012837 · Received March 11, 2008

    Report

    Report Number
    2954730-2008-00110
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 10, 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: 1.8; LAB: 14.0; MEAN: 7.9; CONFIDENCE LIMITS: CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE READINGS ARE CONSIDERED INACCURATE BASED ON "AREA OUTSIDE THE ACCEPTANCE REGION" TABLE. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS REQUIRED AT THIS TIME. STRIP LOT# WAS NOT AVAILABLE, THEREFORE FURTHER TESTING CANNOT BE PERFORMED. ADD'L MODEL# 48 STRIPS, MULTIPACK.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 1.8; LAB: 14.0.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1