BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1321000 · Received February 19, 2009

    Report

    Report Number
    2954730-2009-00041
    Event Type
    Injury
    Date Received
    February 19, 2009
    Date of Event
    January 19, 2009
    Report Date
    February 6, 2009
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 - 2009; INRATIO - 3.5; LAB - 5.7; MEAN - 4.6; CONFIDENCE LIMITS 2.6 - 6.9. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUE ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO FUNCTIONAL TESTING IS REQUIRED. METER NOT EXPECTED TO BE RETURNED, SO NO TESTING POSSIBLE. NO STRIP LOT # PROVIDED BY CUSTOMER, SO NO TESTING OR TRENDING POSSIBLE. NO CORRECTIVE ACTION REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE - 2009; INRATIO - 3.5; LAB - 5.7. THIS IS CONSIDERED AN ADVERSE EVENT, BECAUSE PT HAD A CHANGE IN DOSE AND IS HAVING THE DOSE CHANGED WEEKLY FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention