BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2022515 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00329
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY THE CUSTOMER. INRATIO PRECISION DATA PROVIDED BY END USER LOT: DATE: (B)(6) 2011, 1ST INR: 1.0, 2ND INR: 1.2, MEAN: 1.1, SD: 0.14, %CV: 12.86. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO: 1.0, REFERENCE: 2.8, MEAN: 1.90, CONFIDENCE LIMITS: 1.3 - 2.7; DATE: (B)(6) 2011, INRATIO: 1.2, REFERENCE: 2.8, MEAN: 2.00, CONFIDENCE LIMITS: 1.3 - 2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO VALUES FELL OUTSIDE THE LIMITS; CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. PREVIOUS INVESTIGATION OF STRIP LOT 234527 FROM CASE 140703 MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION IS REQUIRED. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. ANALYSIS OF THE CLIENT'S DATA FROM REPEATED INRATIO TESTS REVEALED THAT TEST RESULT COMPARISON MET PRECISION CRITERIA. RETAIN STRIP TEST RECORD HAS BEEN REVIEWED. CUSTOMER'S OBSERVATION HAS NOT BEEN REPLICATED. NO PRODUCT WAS EXPECTED TO BE RETURNED. RETAIN STRIP TEST RESULT COMPARISON MET ACCURACY CRITERIA. (B)(4). ACTION THRESHOLD HAS BEEN REACHED. SINCE STRIP LOT RELEASED, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE REQUIREMENTS WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION 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: 1.0, LAB: 2.8; DATE: (B)(6) 2011, INRATIO: 1.2, LAB: 2.8. PT THERAPEUTIC RANGE IS 2.0 - 3.0. NO CHANGES IN DIET OR MEDICATIONS (ANTIBIOTICS/OVER THE COUNTER) REPORTED. PT'S INR HAS BEEN STABLE FOR AWHILE. LAST DOES OF COUMADIN WAS TAKEN THE NIGHT BEFORE. PT HAD NO TROUBLE GETTING SAMPLE; PT USES MICROSAFE TUBES. STRIPS ARE STORED AT RT IN THE CASE AND STRIP CODE IS VERIFIED EVERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234527

    Patients

    Seq Age Sex Outcome Treatment
    1 NI