BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1631998 · Received March 5, 2010

    Report

    Report Number
    2027969-2010-00281
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DATA ANALYSIS WAS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. INRATIO PRECISION DATA PROVIDED BY END-USER: DATE: (B) (6) 2010, 1ST INR = 3.8, 2ND INR = 5.4, MEAN = 4.60, SD = 1.13, %CV = 24.60. SINCE 24.60% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. THE 4.5 INR IS EXCLUDED FROM COMPARISON TESTS SINCE IT WAS PERFORMED GREATER THAN 4 HOURS FROM METER RESULTS. SINCE TIME OF TEST 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 BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION ON STRIP LOT 222167 WAS PERFORMED ON A FORMER COMPLAINT AND MET PRECISION CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED. TWO THERAPEUTIC DONOR SAMPLES WERE TESTED ON RETAINS FROM LOT 22167 USING TWO IN-HOUSE METERS AND REFERENCE METER FROM PREVIOUS COMPLAINT. RESULTS ARE AS FOLLOWS: INVESTIGATION RESULTS. PRECISION. DONOR 1: REFERENCE (INR): 2.4, IN-HOUSE (INR): 2.2, IN-HOUSE (INR): 2.2, MEAN: 2.27, SD: 0.12, %CV: 5.09, RESOLUTION: PASS. DONOR 2: REFERENCE (INR): 2.5, IN-HOUSE (INR): 2.9, IN-HOUSE (INR): 2.4, MEAN: 2.60, SD: 0.26, %CV: 10.18, RESOLUTION: PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 222167, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 5.09% AND 10.18%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED. DATA ANALYSIS OF CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA WAS NOT MET. NO PRODUCT IS EXPECTED TO BE RETURNED. RECENT PRECISION TEST RECORD WAS REVIEWED. NO PRODUCT DEFICIENCY WAS ESTABLISHED IN THE TEST DONE WITH RETAIN STRIPS FROM LOT #222167. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF 03/02/2010, 2 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #222167 YIELDING A COMPLAINT RATE OF 0.001%. 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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED POOR CORRELATION WITH ONE PATIENT. RESULTS AS FOLLOWS: INRATIO = 3.8, REPEAT = 5.4. LAB RESULT > 4 HRS LATER = 4.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222167

    Patients

    Seq Age Sex Outcome Treatment
    1