BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 939905 · Received April 13, 2007

    Report

    Report Number
    2954730-2007-00183
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 12, 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: DATE: 2007, INRATIO: 1.7, 1.5, LAB:>3.0, 1.6; MEAN: N/A, 1.55; CONFIDENCE LIMITS CANNOT BE DETERMINED. 1.2-2.3. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, CUSTOMER DIDN'T PROVIDE EXACT LAB RESULT. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED. PER PR, IN-HOUSE RETAINS STRIPS LOT 060452 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MLA INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/- 0.5. IF THE MLA INR IS 2.0-4.5, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/-1.0. THE TEST RESULTS OF RETAINS STRIPS LOTS 060452 DONE IN 2006 ARE AS FOLLOWS: PATIENT 1:(SEE SCANNED TABLE). PATIENT 2: (SEE SCANNED TABLE). BASED ON THE ABOVE TEST RESULTS, PER PR, RETAINED LOT 060452 MEETS THE CRITERIA FOR STRIP ACCURACY.

    Description of Event or Problem · 1

    CALLER ALLEGED, DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; IN RATIO, 1.7, 1.5; LAB >3.0, 1.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060452

    Patients

    Seq Age Sex Outcome Treatment
    1