BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190105 · Received June 30, 2011

    Report

    Report Number
    2027969-2011-01447
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT, DATE: (B)(6) 2011, 1ST INR = 1.6, 2ND INR = 2.0, 3RD INR = 1.9, MEAN = 1.83, SD = 0.21, %CV = 11.38. SINCE %CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. (B)(4). ACTION THRESHOLD (B)(4) HAS BEEN REACHED. (B)(4). TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 1.6, LOT NUMBER: 243934. DATE: (B)(6) 2011, INRATIO: 2.0, LOT NUMBER: 243394. DATE: (B)(6) 2011, INRATIO: 1.9, LOT NUMBER: 243394. TESTS DONE ONE RIGHT AFTER ANOTHER USING A DIFFERENT FS EACH TIME. CUSTOMERS HUSBAND IS CONCERNED ABOUT THE VARIATION BETWEEN THE TWO STRIP LOTS THAT WERE TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1