BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1486212 · Received July 27, 2009

    Report

    Report Number
    2027969-2009-00597
    Event Type
    Malfunction
    Date Received
    July 27, 2009
    Date of Event
    July 8, 2009
    Report Date
    July 27, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, PRODUCTS ASSOCIATED TO THIS COMPLAINT HAVE NOT BEEN RETURNED. INRATIO PRECISION DATA PROVIDED BY END-USER LOT: LOT NO.: 213078; 1ST-INR: 1.6; 2ND-INR: 3.1; 3RD-INR: 2.2. INRATIO METER: MEAN: 2.30; SD: 0.75; %CV: 32.83. SINCE 32.83% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED IF RETURNED. LOT NO.: 213038; 1ST-INR: 1.7; 2ND-INR: 3.0; 3RD-INR: 2.0. INRATIO METER: MEAN: 2.23; SD: 0.68; %CV: 30.48. SINCE 24% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED IF RETURNED. AS OF TODAY, PRODUCTS ASSOCIATED TO THIS COMPLAINT HAVE NOT BEEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS (POOR PRECISION) COMPARISON OF INRATIO TEST COMPARED WITH LAB RESULTS. RESULTS AS FOLLOWS: LOT NO.: 213078; 1ST-INR: 1.6; 2ND-INR: 3.1; 3RD-INR: 2.2. LOT NO.: 213038; 1ST-INR: 1.7; 2ND-INR: 3.0; 3RD-INR: 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100004 213078

    Patients

    Seq Age Sex Outcome Treatment
    1 NI