BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 843780 · Received April 30, 2007

    Report

    Report Number
    2954730-2007-00212
    Event Type
    Injury
    Date Received
    April 30, 2007
    Date of Event
    April 20, 2007
    Report Date
    April 26, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    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 2007. INRATIO: 2.7, 3.3. LAB: 10.18, 9.76. MEAN: 6.44, 6.53 CONFIDENCE LIMITS: CANNOT BE DETERMINED, CANNOT BE DETERMINED. PER INTERNAL PROCEDURE, TR 0150, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE CONFIDENCE LIMITS CANNOT BE DETERMINED. PATIENT WAS SENT TO THE HOSPITAL FOR VITAMIN K INTERVENTION. THIS IS ADVERSE EVENT. THE STRIP LOT ( 050557) PROVIDED BY CUSTOMER WAS EXPIRED ON 8/31/2006. RETAIN STRIPS WERE KEPT TWO MONTHS AFTER EXPIRATION DATA. RETAIN STRIPS WERE UNAVAILABLE FOR TESTING. PRODUCTS WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: IN 2007. INRATIO 2.7. 3.3. LAB: 10.18, 9.76.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 050557

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization