BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1163623 · Received September 2, 2008

    Report

    Report Number
    2954730-2008-00532
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 27, 2008
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    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: (B) (6) 2008, INRATIO: 1.9, LAB: 5.7, MEAN: 3.8, CONFIDENT LIMITS: 2.3-5.7 ((B) (6) 2008). THE INRATIO VALUE IS NOT WITHIN THE CONFIDENT LIMIT AS PER INTERNAL PROCEDURE. PRODUCT WILL BE INVESTIGATED. ALSO THE PATIENT PERFORMED THE LAB TEST ONE DAY PRIOR TO INRATIO TEST. AS PER THE INTERNAL PROCEDURE, THE TIME EXCEEDS THREE HOURS THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: (B) (6) 2008, INRATIO: 1.9, LAB: 5.7 ((B) (6) 2008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100004 070781A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI