BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1628421 · Received March 2, 2010

    Report

    Report Number
    2027969-2010-00261
    Event Type
    Malfunction
    Date Received
    March 2, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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) 2010, INRATIO: 1.5, REFERENCE: 9.0, MEAN: 5.25. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADDITIONAL INVESTIGATION IS REQUIRED. INR REPORTED DID NOT MEET ACCURACY CRITERIA. PREVIOUS INVESTIGATION ON STRIP LOT # 220375 FROM A PRIOR CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED. CONCLUSION: DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE OUTSIDE OF THE ACCEPTANCE REGION FOR REFERENCE INR VALUE >7.5 AND INRATIO INR <5.0. COMPARISON OF THE TWO VALUES IS CONSIDERED INACCURATE. NO PRODUCT IS EXPECTED TO BE RETURNED. PT TAKING ANTIBIOTICS MAY AFFECT INRATIO TEST. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 03/01/2010, 9 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220375 YIELDING A COMPLAINT RATE OF 0.002%. 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 AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 1.5, LAB: 9.0. PT HAS NO SIGNS OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220375

    Patients

    Seq Age Sex Outcome Treatment
    1