BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1566531 · Received December 4, 2009

    Report

    Report Number
    2027969-2009-01141
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    September 25, 2009
    Report Date
    December 4, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    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: 4.0; REF: 2.4; MEAN: 3.20; CONFIDENCE LIMITS: 1.9 -4.6. THE MEAN OF THE INRATIO METER 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. INRATIO RESULT PROVIDED BY THE CUSTOMER IS REGISTERED ON MEMORY AND IS WITHIN THE CONFIDENCE LIMITS. BASED ON MEMORY, CUSTOMER UTILIZED (B)(4) ON REPORTED INR. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT 220408. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR LOT 220408 ARE WITHIN ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. ORIGINAL MEAN CALCULATION REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. PRODUCTS IN COMPLAINT HAVE BEEN RETURNED. IN-HOUSE PRODUCT TESTS DID NOT FIND PRODUCTS TO BE DEFECTIVE. METER MEMORY RECORD REVEALED REPEATED TEST VALUE WAS 2.26 (REFERENCE 2.2). TEST AND REPEATED TEST WERE 15 MINUTES APART. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. REPLACEMENT STRIPS WERE SENT. THE OUTCOME OF COMPLAINT INVESTIGATION DOES NOT DEMONSTRATE A POTENTIAL DEFICIENCY OF A PRODUCT. FURTHER ESCALATION IS NOT REQUIRED. AS OF 11/30/2009, 11 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220408 YIELDING A COMPLAINT RATE OF 0.003%. 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 IS NOT REQUIRED AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2009; INRATIO: 4.0; LAB: 2.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 221726

    Patients

    Seq Age Sex Outcome Treatment
    1