BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1522158 · Received October 27, 2009

    Report

    Report Number
    2027969-2009-00972
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 27, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: INRATIO: 2.0, REF: 1.0, MEAN: 1.5, CONFIDENCE LIMITS: 1.1-1.9. INRATIO: 4.5, REF: 2.1, MEAN: 3.30, CONFIDENCE LIMITS: 1.9-4.6. PER EVENT DETAILS, TESTS ARE CONDUCTED 5-10 MINUTES INTERVAL. AT 2.0 INR IS NOT REGISTERED ON MEMORY AND IT IS NOT WITHIN THE CONFIDENCE LIMITS. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT 220375. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND SYSMEX INRS WERE CALCULATED. FOR STRIP LOT 220375, AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND NO FURTHER ACTION IS REQUIRED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    TWO PATIENTS ALLEGED DISCREPANT RESULTS COMPARED WITH THEIR LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: 2.0, LAB: 1.0. INRATIO: 4.5, LAB: 2.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 0100139 220375

    Patients

    Seq Age Sex Outcome Treatment
    1 NI