BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTIME3 MICROCOAGULATION SYSTEM

    MDR report key: 487080 · Received September 25, 2003

    Report

    Report Number
    2248721-2003-00001
    Event Type
    Other
    Date Received
    September 25, 2003
    Date of Event
    August 26, 2003
    Report Date
    September 24, 2003
    Manufacturer
    ITC
    Product Code
    GJS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING 2003, SOME CORRELATIONS DEMONSTRATED A BIAS OF THE PROTIME3 INR, SHOWING A GENERAL TENDENCY TO YIELD HIGHER INRS COMPARED TO THE LABORATORY REFERENCE. WHILE VARIABILITY OF INR DUE TO TEST SYSTEM IS KNOWN TO EXIST IN THE CLINICAL COMMUNITY, THESE REPORTS WERE ESCALATED FOR REVIEW IN AN INTERNAL SURVEILLANCE SYSTEM DUE TO A CONCURRENT INCREASE OF CUSTOMER COMPLAINTS WITH TWO SPECIFIC LOTS OF PROTIME CUVETTES, IN WHICH CUSTOMERS REPORTED "HIGHER THAN EXPECTED INRS". REPORTS ALSO INCLUDED A HIGH INCIDENCE OF THE CUVETTE INTERNAL CONTROLS YIELDING OUT-OF-RANGE RESULTS AND THIS BEING REPORTED AS A TEST ERROR (81-F3), NOT AS AN INR. BASED UPON THESE OBSERVATIONS, THE MANUFACTURER VOLUNTARILY INITIATED A COMPREHENSIVE SCREENING OF ALL PROTIME3 LOTS MANUFACTURED IN THE TIME PERIOD ASSOCIATED WITH THESE LOTS. THIS REPORT IS SUBMITTED, BASED UPON THE FINDINGS OF THAT SCREENING AND AS NOTIFICATION OF CO'S INTENTION TO REMOVE SPECIFIC LOTS OF PROTIME3 MATERIAL FROM THE FIELD, WHICH HAVE A GREATER THAN EXPECTED VARIABILITY, WITH RESPECT TO THE LAB STANDARD. THIS IS A VOLUNTARY ACTION TO MAINTAIN THE PROTIME3 PERFORMANCE STANDARD, AS THERE HAVE GENERALLY BEEN FEW CUSTOMER COMPLAINTS, BEYOND THE ABOVE NOTED LOTS, AND NO REPORTS OF ADVESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTIME3 MICROCOAGULATION SYSTEM POC PROTHROMBIN TIME TEST GJS ITC PROTIME3 C101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other