BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1393902 · Received May 19, 2009

    Report

    Report Number
    2027969-2009-00338
    Event Type
    Injury
    Date Received
    May 19, 2009
    Date of Event
    April 21, 2009
    Report Date
    May 19, 2009
    Manufacturer
    BIOSITE INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: 2009, 1ST INR = 4.0, 2ND INR = 2.0. INRATIO METER MEAN 3.0, SD 1.4, %CV 47.1. THE 47.1% CV IS MORE THAN 20%. THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. PRODUCTS WILL BE TESTED WHEN IT IS RETURNED. NO STRIPS IN COMPLAINT WERE RETURNED. HOWEVER, METER IN COMPLAINT WAS RETURNED AND RECEIVED. THE %CV CALCULATION REVEALED CV% ABOVE 20%. FURTHER INVESTIGATION WAS REQUIRED. IN-HOUSE TESTING WAS PERFORMED ON RETURNED METER VS. SYSMEX WITH THERAPEUTIC SAMPLE AND RETAIN STRIPS. ALL RESULTS MET PRECISION CRITERIA. FUNCTIONAL TEST WAS PERFORMED ON RETURNED METER. ALL TEST CRITERIA PASSED. NO PRODUCT DEFICIENCY WAS ESTABLISHED. FURTHER ACTION IS NOT REQUIRED AT THIS TIME. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF END-USER'S PRECISION DISCREPANCY. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. IN-HOUSE PRECISION TESTING PROVIDED (INRATIO METER): DONOR 1: INR 2.6, INR 2.5, MEAN 2.55, SD 0.07, %CV 2.77%, PASS. DONOR 2: INR 2.4, INR 2.4, MEAN 2.50, SD 0.00, %CV 0.00%, PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. BOTH TESTS, WHICH HAVE 2.77% CV AND 0% CV FOR EACH DONOR, ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. PRODUCT DEFICIENCY IS NOT PRODUCED. NO FURTHER ACTION IS REQUIRED. AS OF 2009, 30 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #080584 YIELDING A COMPLAINT RATE OF 0.006%. 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 ALLEGED IMPRECISION WITH INRATIO METER RESULTS AS FOLLOWS:" 2009, 1ST RESULT = 4.0; REPEAT = 2.0. THIS IS CONSIDERED AN ADVERSE EVENT BECAUSE CUSTOMER REPORTED THAT DR WITHHELD COUMADIN BASED ON INITIAL HIGH INR RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INC. 0100139 080584A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI