BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 2972012 · Received February 18, 2013

    Report

    Report Number
    2027969-2013-00150
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO: 1.8, REFERENCE: 3.8, MEAN: 2.80, CONFIDENCE LIMITS: 1.7 - 3.8. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE 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. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 289504 ON (B)(6) 2013. RESULTS AS FOLLOWS: DONOR (B)(6), INRATIO: 2.7, INRATIO: 2.4 INRATIO: 2.5, REF: 2.29, BIAS THRESH: 1.29 - 3.29, %CV: 6.03. DONOR (B)(6), INRATIO: 2.9, INRATIO: 2.9, INRATIO: 3.1, REF: 2.77, BIAS THRESH: 1.77 - 3.77, %CV: 3.89. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAS BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.8, LAB: 3.8. TIME BETWEEN TESTING WAS REPORTED AS 3 HOURS. PATIENT'S THERAPEUTIC RANGE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70940 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 289504

    Patients

    Seq Age Sex Outcome Treatment
    1 LEVOTHYROXINE| STOPPED COUMADIN FOR ABLATION PROCEDURE