BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1193121 · Received October 6, 2008

    Report

    Report Number
    2954730-2008-00586
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 1, 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: 2008, INRATIO: 1.8, LAB: 4.8, MEAN: 3.3, CONFIDENT LIMITS: 2.0-5.0. AS PER INTERNAL PROCEDURE, THE INRATIO VALUE IS NOT WITHIN THE CONFIDENT LIMIT. THE PRODUCT WILL BE INVESTIGATED. THE CALLER ALSO DID ANOTHER CORRELATION WITH ANOTHER PERSON AND GOT A .2 VARIANCE. BUT THEY DID NOT GIVE THE READING FOR CALCULATING THE CONFIDENT LIMITS.

    Description of Event or Problem · 1

    THE CALLER ALLEGED DISCREPANT RESULTS WHEN COMPARED WITH THE LAB RESULTS REPORTED AS FOLLOWS: DATE: 2008, INRATIO: 1.8, LAB: 4.8. ASKED CUSTOMER TO REVIEW PATIENT DETAILS IN DEPTH TO DETERMINE THE CAUSE OF THE INTERFERENCE. PATIENT ALSO HAD A CBC DONE AND IT WAS 33. CUSTOMER IS REQUESTING A SALES REP DO AN INSERVICE TO DETERMINE METER IS ACCURATE. CUSTOMER DID NOT WANT TO LISTEN TO TSR ON POSSIBLE QC TESTING. TSR UNABLE TO DETERMINE THE CAUSE OF THE INTERFERENCE. RGA CREATED FOR METER DUE TO INTERVENTION ON PATIENT, CUSTOMER UNWILLING TO USE METER DUE TO ACCURACY QUESTIONS. TSR WILL ALSO CONTACT REP AT CUSTOMERS REQUEST FOR FOLLOW UP. PLEASE SEND REPLACEMENT METER AND RGA KIT AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0100007 070770A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI