BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1491024 · Received July 31, 2009

    Report

    Report Number
    2027969-2009-00617
    Event Type
    Malfunction
    Date Received
    July 31, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 30, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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: 4.1, LAB: 3.3, MEAN: 3.70, CONFIDENCE LIMITS: 2.2-5.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB 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. FUNCTIONAL TESTING IS NOT REQUIRED AT THIS TIME; METER AND STRIPS ARE NOT EXPECTED TO BE RETURNED. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. AS OF 07/15/2009, 25 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #080868 YIELDING A COMPLAINT RATE OF 0.008%. 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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME 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: 4.1, LAB: 3.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100007 080868

    Patients

    Seq Age Sex Outcome Treatment
    1 NI