BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1627527 · Received March 1, 2010

    Report

    Report Number
    2027969-2010-00243
    Event Type
    Injury
    Date Received
    March 1, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 METER = 6.6 INR; REFERENCE = 4.0 INR; MEAN = 5.30. 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. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY CRITERIA WAS NOT MET IN TWO OUT OF THREE COMPARISONS. NO PRODUCT IS EXPECTED TO BE RETURNED. PT'S ON MEDICATION FOR HYPOTHYROIDISM AND IT MAY AFFECT INRATIO INR TEST RESULT. ACCURACY TEST DONE ON CASE (B) (6) INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED IN RETAIN STRIP FROM LOT #221727. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 02/26/2010, 16 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #221727 YIELDING A COMPLAINT RATE OF 0.004%. 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. NO CORRECTIVE ACTION IS 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: 6.6; LAB: 4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 221727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention