BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589164 · Received January 11, 2010

    Report

    Report Number
    2027969-2010-00025
    Event Type
    Malfunction
    Date Received
    January 11, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 11, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. CUSTOMER RESULTS ANALYZED AND ACCURACY CONFIDENCE LIMITS WERE MET - ALL RESULTS. PRODUCT DEFICIENCY NOT ESTABLISHED. FURTHER ACTION NOT REQUIRED. AS OF 1/07/2009, 1 DISCREPANT RESULT COMPLAINT WAS REPORTED FOR LOT #223042 YIELDING A COMPLAINT RATE OF 0.000%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: WEEK 1, INRATIO: 4.7, LAB: 3.45; WEEK: 2, INRATIO: 2.9, LAB: 2.3; WEEK: 3, INRATIO: 3.3, LAB: 2.8; WEEK: 4, INRATIO: 2.2, LAB: 3.95. (PATIENT INRS FROM THE LAST FOUR WEEKS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 223042

    Patients

    Seq Age Sex Outcome Treatment
    1