BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1544811 · Received November 4, 2009

    Report

    Report Number
    2027969-2009-01001
    Event Type
    Malfunction
    Date Received
    November 4, 2009
    Date of Event
    October 7, 2009
    Report Date
    November 4, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    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 220408: 1ST INR = 4.3, 2ND INR = 3.3. INRATIO METER: MEAN: 3.80; SD: 0.71; %CV: 18.61. SINCE 18.61% CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. DONOR 1: (INR) RETURNED: 2; (INR) IN-HOUSE: 2.2; MEAN: 2.10; SD: 0.14; %CV: 6.73; RESOLUTION: PASS. DONOR 2: (INR) RETURNED: 4.1; (INR) IN-HOUSE: 3.4; MEAN: 3.75; SD: 0.49; %CV: 13.20; RESOLUTION: PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 220408, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 6.73% AND 13.20%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB 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. ACCURACY TEST WAS PERFORMED ON RETURNED METER. ACCURACY CRITERIA MET. METER FUNCTIONAL TEST WAS PERFORMED. ALL BUT SAMPLE INDICATOR TEST PASSED. SAMPLE INDICATOR WAS ON IN SAMPLE TEST. ISSUE WAS NOT RELATED TO METER, BUT TESTER PLATFORM. INR 4.3 IN COMPLAINT WAS NOT FOUND IN METER MEMORY. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2009; INRATIO: 4.3; INRATIO (DIFFERENT METER): 3.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 0100139 220408

    Patients

    Seq Age Sex Outcome Treatment
    1 NI