BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 753094 · Received July 28, 2006

    Report

    Report Number
    2954730-2006-00425
    Event Type
    Malfunction
    Date Received
    July 28, 2006
    Date of Event
    July 27, 2006
    Report Date
    July 27, 2006
    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 IN 2006; INRATIO 1.2; LAB 5.1; MEAN 3.15; CONFIDENCE LIMITS 1.9-4.6. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE OUTSIDE THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS WILL BE INVESTIGATED. RESULTS OF TESTING PERFORMED ON 7/14/2006. PER PR, RETAIN STRIPS LOT 060102 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLOWS: 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 RETAIN STRIPS LOT 060102 TEST RESULTS ARE AS FOLLOWS: PLEASE SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, PER PR, RETAIN STRIPS LOT 060102 MEETS THE CRITERIA FOR STRIP ACCURACY.)

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE IN 2006; INRATIO 1.2; LAB 5.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. * 060102

    Patients

    Seq Age Sex Outcome Treatment
    1 *