BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1514246 · Received October 5, 2009

    Report

    Report Number
    2027969-2009-00904
    Event Type
    Malfunction
    Date Received
    October 5, 2009
    Date of Event
    September 15, 2009
    Report Date
    October 5, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    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: (B)(6) 2009, INRATIO: 0.9, REF: 1.9, MEAN: 1.40, CONFIDENCE LIMITS: 1.1-1.9. INRATIO: 6.8, REF: 9.0, MEAN: 7.90, CONFIDENCE LIMITS: UNDETERMINABLE. A 6.8 INR IS REGISTERED ON (B)(6) 2009, BUT 0.9 INR IS NOT REGISTERED ON UNIT. SINCE TEST 1 FALLS OUTSIDE THE CONFIDENCE LIMITS, STRIP INVESTIGATION WAS PERFORMED ON RETURNED STRIP LOT 220408 (B)(4). THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES OF STRIP LOT 220408 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0200457 220408

    Patients

    Seq Age Sex Outcome Treatment
    1 NI