BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1021489 · Received March 26, 2008

    Report

    Report Number
    2954730-2008-00140
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 24, 2008
    Manufacturer
    HEMOSENSE SJ
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: 2008; INRATIO: 1.5; LAB: 7.8; MEAN: 4.7; 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 VALUES ARE NOT WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE FURTHER TESTING IS REQUIRED AT THIS TIME. THIS CASE QUALIFIES AS AN ADVERSE EVENT. PRODUCT WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2008; INRATIO: 1.5; LAB: 7.8. THIS CASE QUALIFIES AS AN ADVERSE EVENT. MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT. VITAMIN K WAS GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE SJ KIT, PROFESSIONAL USER, ENGLISH 070308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention