BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1472673 · Received July 6, 2009

    Report

    Report Number
    2027969-2009-00542
    Event Type
    Malfunction
    Date Received
    July 6, 2009
    Date of Event
    June 16, 2009
    Report Date
    July 2, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CALLER OBTAINED METER VALUE OF 6.8, REPEATED THE METER TEST AND OBTAINED 5.7; LAB RESULT WAS 4.2. OBTAINED 7.2 WITH ANOTHER PATIENT, THIS VALUE NOT EVALUATED BECAUSE NO COMPARISON VALUE GIVEN. TIME ELAPSED BETWEEN METER TESTS AND LAB TEST WAS NOT GIVEN. THE %CV IS LESS THAN 20%. THE PRECISION CRITERION IS MET. PRODUCT PRECISION TESTING IS NOT REQUIRED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: SET: 1, METER: 6.8, LAB: 4.2, MEAN: 5.5. SET: 2, METER: 5.7, LAB: 4.2, MEAN: 4.95, CONFIDENCE LIMITS: 2.8-7.2. FOR SET 2, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WAS CALCULATED. THE INR VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS FOR SET 2 ARE NOT CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FOR SET 1, THE MEAN IS GREATER THAN 5.0 AND DIFFERENCE BETWEEN INR'S IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE. PRODUCT ACCURACY TESTING IS REQUIRED. PRODUCTS ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED. STRIP ACCURACY TESTING WILL BE PERFORMED USING RETAIN STRIP LOT NUMBER 213040.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PATIENT 1: INRATIO 6.8, REPEAT USING METER 5.7 LAB 4.2. PATIENT 2: INRATIO 7.2, THIS PATIENT WAS NOT RE-TESTED OR SENT TO THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 0100139 213040

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN