BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1549863 · Received November 14, 2009

    Report

    Report Number
    2027969-2009-01036
    Event Type
    Malfunction
    Date Received
    November 14, 2009
    Date of Event
    October 16, 2009
    Report Date
    November 12, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2009: 1ST INR = 5.4; 2ND INR = 5.1. THE 3.9 IS EXCLUDED FROM COMPARISON TEST SINCE IS DONE MORE THAN 3 HOURS APART. CUSTOMER ALSO OBTAINED 444 ERROR. INRATIO METER: MEAN: 5.25, SD: 0.21, %CV: 4.04. SINCE 4.04% CV IS LESS THEN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. THE 3.9, 5.4 AND 5.1 INR READINGS WERE PERFORMED MORE THAN 3 HOURS APART AND ARE THEREFORE, EXCLUDED FROM COMPARISON TESTING. SINCE TIME OF TESTS EXCEEDED THREE HOURS THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME IN BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. INVESTIGATION REQUIREMENTS: TEST DATE: DONOR 1: (B)(6) 2009, DONOR 2: (B)(6) 2009. SERIAL NUMBERS: RETURNED METER: (B)(4), IN-HOUSE METER: (B)(4). TYPE OF TEST: PRECISION: RETAINED STRIP: STRIP LOT: 220377, STRIP CODE: WY1UA, QUANTITY: 6. BASED ON MEMORY, CUSTOMER UTILIZED STRIP CODE G41ZN WITH STRIP LOT 80868B. SINCE STRIP LOT 080868B IS UNAVAILABLE, ANY STRIP CODE REGISTERED ON MEMORY CAN BE UTILIZED. COMPARATIVE SYSTEM: SYSMEX 560. TYPE OF DONORS: THERAPEUTIC. FUNCTIONAL TEST: YES. VISUAL INSPECTION: YES. INVESTIGATION RESULTS: DONOR 1: RETURN (INR): 2.2, IN-HOUSE (INR): 2.1, MEAN: 2.15, SD: 0.07, %CV: 3.29, RESOLUTION: PASS. DONOR 2: 2.5, 2.2, 2.35, 0.21, 9.03, PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 220377, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 3.29% AND 9.03%, 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. THERE IS NO CLINICAL SIGNIFICANCE IN THE DISCREPANCY ANALYSIS FOR CUSTOMER DID NOT PROVIDE REFERENCE VALUE TO CALCULATE THE CONFIDENT LIMIT. TWENTY-FOUR TEST ERRORS (NES/4NN) WERE FOUND IN METER MEMORY. METER FUNCTIONAL TESTS WERE PERFORMED. PRECISION CRITERIA WAS MET. METER DEFICIENCY WAS NOT ESTABLISHED. THE ROOT CAUSE FOR END-USER'S DISCREPANCY COULD NOT BE DETERMINED WITHOUT SUFFICIENT INFORMATION. IT IS POSSIBLE PATIENT'S CONDITION/MEDICATIONS MIGHT AFFECT INRATIO TEST RESULT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. TREND ANALYSIS IS NOT REQUIRED - CUSTOMER'S OBSERVATION OCCURRED IN EVERY LOT USED FROM METER MEMORY RECORD.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009: INRATIO: 5.4; 5.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 0100071 214532

    Patients

    Seq Age Sex Outcome Treatment
    1 NI