BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1211113 · Received October 23, 2008

    Report

    Report Number
    2954730-2008-00620
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 22, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    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: 2008; INRATIO: 1.9; LAB: 2.1; MEAN: 2.0; CONFIDENT LIMITS: 1.3 - 2.7. DATE: SAME DAY; INRATIO: 2.0; LAB: 3.5; MEAN: 2.75; CONFIDENT LIMITS: 1.7 - 3.8. DATE: SAME DAY; INRATIO: 4.8; LAB: 3.9; MEAN: 4.35; CONFIDENT LIMITS: 2.5 - 6.5. INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENT LIMIT AS PER OUR INTERNAL PROCEDURE. THE PT DOSAGE CHANGE OF MEDICINE AFTER THE TEST 2 AND 3. THIS IS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008; INRATIO: 1.9; LAB: 2.1. DATE: SAME DAY; INRATIO: 2.0; LAB: 3.5. DATE: SAME DAY; INRATIO: 4.8; LAB: 3.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100071 080076A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention