BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1112012 · Received August 12, 2008

    Report

    Report Number
    2954730-2008-00497
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 7, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF REPEAT INRATIO TEST PROVIDED BY END-DISCREPANT RESULTS (ACCURACY) COMPARISON OF REPEATED INRATIO TEST PROVIDED BY END-DISCREPANT RESULTS (ACCURACY). COMPARISON OF REPEATED INRATIO PROVIDED BY ENDUSER AT THE TIME THE COMPLAINT WAS FILED ARE AS FOLLOWS: REPEATED INRATIO ON THE EVENT DATE: TEST #1: 1.9, TEST#2: 5.5, TEST#3: 2.2, AVERAGE: 3.2, SD: 1.997498, %CV: 62.42%. THE %CV IS GREATER THAN 20% AND CRITERIA IS NOT MET AS PER INTERNAL PROCEDURE (REV 2), SO FUNCTIONAL TESTING WILL BE PERFORMED AS PART OF THE COMPLAINT INVESTIGATION. PRODUCT WILL BE INVESTIGATED. ALSO PT IS TAKING ANTIBIOTIC WHICH MIGHT CAUSE OF THE DISCREPANT RESULTS AND ALSO THE PT WHEN TESTING DOES NOT DRY OFF ALCOHOL PRIOR TO STICKING HIMSELF.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS DURING THE REPEATED TEST WITH INRATION. THE REPEATED TEST RESULTS (ON THE EVENT DATE) ARE AS FOLLOWS: TEST #1 1.9, TEST#2 5.5, TEST#3 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NI