BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1621431 · Received February 16, 2010

    Report

    Report Number
    2027969-2010-00185
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 16, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. INR REPORTED MEETS ACCURACY CRITERIA. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT THE TIME COMPLAINT WAS FILED: DATE: (B) (6) 2010; INRATIO METER = 3.3 INR; REFERENCE = 2.2 INR; MEAN = 2.75. CONFIDENCE LIMITS = 1.7-3.8. 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. SUMMARY: DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED 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. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF PT'S TEST RESULT DISCREPANCY. AS OF 02/15/2010, 5 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #210832 YIELDING A COMPLAINT RATE OF 0.007%. 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.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT RESULTS COMPARED TO A REFERENCE (COAGUCHECK). INRATIO2 RESULT = 3.3. COAGUCHECK RESULT = 2.2. PT'S THERAPEUTIC RANGE IS 2.0 - 3.0. PT HAS HAD NO PHYSICAL CHANGES OR NEW MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 210832

    Patients

    Seq Age Sex Outcome Treatment
    1