BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 960211 · Received December 3, 2007

    Report

    Report Number
    2954730-2007-00597
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 27, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING FOR THE LAST 3 DATA SETS. FOR THE FIRST 2 DATA SETS, BOTH INRATIO AND LAB VALUES ARE NOT WITHIN THE CONFIDENCE LIMITS. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. INRATIO PRECISION DATA PROVIDED BY EN-USER LOT: 070325. FIRST TEST INR = 1.2, SECOND TEST INR = 1.2; MEAN = 1, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: CALLER ALLEGES IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070325

    Patients

    Seq Age Sex Outcome Treatment
    1 YR