BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1474827 · Received June 22, 2009

    Report

    Report Number
    2027969-2009-00470
    Event Type
    Malfunction
    Date Received
    June 22, 2009
    Date of Event
    May 26, 2009
    Report Date
    June 22, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. DISCREPANT RESULTS COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER FOLLOWING INITIAL COMPLAINT: SET 1, METER: 2.0, LAB: 1.4, MEAN: 1.7, CONFIDENCE LIMITS: 1.2-2.3. SET 2, METER: 2.4, LAB: 1.7, MEAN: 2.05, CONFIDENCE LIMITS: 1.4-3.1. THE TIME ELAPSED BETWEEN TESTS WAS NOT GIVEN. THE MEANS OF THE INRATIO METER AND COMPARATIVE SYSTEM INR'S WERE CALCULATED. THE INR VALUES FOR BOTH SETS ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PRODUCT TESTING IS NOT REQUIRED. RECEIVED METER (B)(4) AND 6 STRIPS LN 213039. METER FUNCTIONAL TESTING WAS PERFORMED AND PASSED. NO CORRECTIVE ACTION REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2009, INRATIO: 3.9, LAB: 2.4. ON 6/1: CUSTOMER CALLED BACK WITH MORE COMPARISON DATA: PT 1: INRATIO 2.8, LAB 2.3. PT 2: INRATIO 3.7, LAB 3.1. PT 3: INRATIO 2.2, LAB 1.8. PT 4: INRATIO 2.8, LAB 2.2. ON 06/4: CUSTOMER CALL BACK AGAIN WITH MORE DATA: INRATIO 2.0, LAB: 1.4. INRATIO: 2.4, LAB: 1.7.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI