BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1082071 · Received July 23, 2008

    Report

    Report Number
    2954730-2008-00474
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: 2008; INRATIO: 4.3; LAB: 2.7; MEAN: 3.5; CONFIDENCE LIMITS: 2.0-5.0; DATE: 2008; INRATIO: 4.8; LAB: 3.8; MEAN: 4.3; CONFIDENCE LIMITS: 2.5-6.3. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS NOT REQUIRED AT THIS TIME. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 4.3; LAB: 2.7. DATE: 2008; INRATIO: 4.8; LAB: 3.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 070761

    Patients

    Seq Age Sex Outcome Treatment
    1 NI