BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1505204 · Received September 25, 2009

    Report

    Report Number
    2027969-2009-00875
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 25, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT ACCURACY RESULTS. COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END USER AT TIME COMPLAINT WAS FILED. DATE: (B)(6) 2009, INRATIO: 2.5, REFERENCE: 4.9; DATE: (B)(6) 2009, INRATIO: 1.4, REFERENCE: 6.0. INVESTIGATION WAS PERFORMED FOR THE INRATIO2 METER. TWO STRIP TESTS WERE CONDUCTED ON DIFFERENT STRIPS LOTS. STRIP LOT 210832 (CODE: 7L1D2) IS USED BY THE CUSTOMER AS SHOWN ON DATA MEMORY AND STRIP LOT 214539 IS RETURNED BY THE CUSTOMER, BUT IS NOT REGISTERED ON METERS MEMORY. INVESTIGATION RESULTS: STRIP TEST ON RETAINED STRIP LOT 210832. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THERE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 210832 ARE WITHIN THE ALLOWABLE BIAS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. NO STRIP DEFICIENCY WAS ESTABLISHED. STRIP TEST ON RETURNED STRIP LOT 214539. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATED FOR BOTH SAMPLES FOR STRIP LOT 214539 ARE WITHIN THE ALLOWABLE BIAS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. NO STRIP DEFICIENCY WAS ESTABLISHED. (B)(4). NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    DISCREPANT ACCURACY RESULTS. PATIENT: 1, INRATIO: 2.5, LAB: 4.9; PATIENT: 2, INRATIO: 1.4, LAB: 6.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100139 214539

    Patients

    Seq Age Sex Outcome Treatment
    1 NI