BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1589187 · Received January 13, 2010

    Report

    Report Number
    2027969-2010-00036
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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) 2009; INRATIO METER = 3.3 INR; REFERENCE = 7.0 INR; MEAN = 5.15; CONFIDENCE LIMITS = UNABLE TO DETERMINE. 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. PER GENERAL DESCRIPTION, CUSTOMER LEFT THE STRIPS AND METER IN THE CAR OVERNIGHT. THE MONITOR AND TEST STRIP MUST BE AT ROOM TEMP BEFORE USE AS INDICATED ON USER GUIDE. INITIAL CUSTOMER COMMUNICATION REVEALED PRODUCT WAS STORED IN -20F CAR. THE ENVIRONMENT ADVERSELY AFFECTS OR INFLUENCES DEVICE USE. IN-HOUSE ACCURACY TEST WITH RETAIN STRIP REVEALED PRODUCT DEFICIENCY WAS NOT ESTABLISHED. AS OF (B) (6) 2010, 26 DIFFERENT RESULTS COMPLAINT WAS REPORTED FOR LOT # 216965 YIELDING A COMPLAINT RATE OF 0.014%. 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. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR LOT 216965 ARE WITHIN ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2009; INRATIO: 3.3; LAB: 7.0. DATE: (B) (6) 2009; INRATIO: 8.0; LAB: -.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 216965

    Patients

    Seq Age Sex Outcome Treatment
    1