BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1496086 · Received August 26, 2009

    Report

    Report Number
    2027969-2009-00725
    Event Type
    Malfunction
    Date Received
    August 26, 2009
    Date of Event
    July 31, 2009
    Report Date
    August 26, 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
    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: DATE: (B)(6) 2009; INRATIO: 1.2; LAB: 2.5; MEAN: 1.85; CONFIDENCE LIMITS: 1.3-2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIPS ACCURACY AND/OR PRECISION TESTING AS PART OF THE COMPLAINT INVESTIGATION WHEN METER IS RETURNED. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME UPDATE TO COMPLAINT WAS FILED: DATE: (B)(6) 2009; INRATIO: 1.2; LAB: 3.5; MEAN: 2.35; CONFIDENCE LIMITS: 1.6-3.4. 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. THIS WOULD BE SUBJECT TO STRIPS ACCURACY AND/OR PRECISION TESTING AS PART OF THE COMPLAINT INVESTIGATION WHEN METER IS RETURNED. THIS DATA IS REFERENCED FROM A PREVIOUS COMPLAINT FOR STRIP LN 210831PA. STRIP LN 210831 IS UNAVAILABLE, SO RETAINED STRIP LN 210831PA IS UTILIZED. IN-HOUSE ACCURACY TEST: DONOR 5 ((B)(6) 2009); DONOR 6 ((B)(6) 2009). METERS SN: REFENCED METER FROM PREVIOUS COMPLAINT (B)(4). IN-HOUSE METERS (B)(4). RETAINED STRIP: 210831PA. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR EACH LOT ARE WITHIN THE ALLOWABLE BIAS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. NO STRIP DEFICIENCY WAS ESTABLISHED. AS OF 08/26/2009, 8 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #210831, 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. METER WILL BE TESTED WHEN IT IS RETURNED. NO CORRECTIVE ACTION IS 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: 1.2; LAB: 2.5. DATE: (B)(6) 2009; INRATIO: 1.2; LAB: 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 0100004 210831

    Patients

    Seq Age Sex Outcome Treatment
    1 NI