BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1549857 · Received November 14, 2009

    Report

    Report Number
    2027969-2009-01062
    Event Type
    Malfunction
    Date Received
    November 14, 2009
    Date of Event
    October 27, 2009
    Report Date
    November 13, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2009, INRATIO METER = >7.5 INR; 7.5 INR HAS BEEN UTILIZED FOR COMPARISON TEST. REFERENCE = 1.7, MEAN = 4.60, CONFIDENCE LIMITS = 2.5-6.5. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. CUSTOMER RESULTS ANALYZED AND ACCURACY CRITERIA NOT MET. PREVIOUS IN-HOUSE TEST ON STRIP LOT #080731A (B)(4) REVEALED ACCURACY MET CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. AS OF 11/13/2009, 4 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #080731 YIELDING A COMPLAINT RATE OF 0.04%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AS PRODUCT DEFICIENCY NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: >7.5, LAB: 1.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 080731A

    Patients

    Seq Age Sex Outcome Treatment
    1