BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2123347 · Received June 10, 2011

    Report

    Report Number
    2027969-2011-01309
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    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) 2011, INRATIO METER = 5.0 INR, REFERENCE = 3.3 INR , MEAN = 4.15, CONFIDENCE LIMITS = 2.4-6.1. 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. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. AS OF 06/09/2011, NO STRIP LOT INFO WAS PROVIDED NOR IS PRODUCT EXPECTED TO RETURN. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. NO STRIP LOT INFO WAS PROVIDED, AND NO PRODUCT WAS EXPECTED TO BE RETURNED. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO CUSTOMER PROVIDED. STRIPS WERE BEING STORED IN A CAR. PER PRODUCT USER GUIDE - STORAGE AND HANDLING INSTRUCTION, "STORE STRIPS AT ROOM TEMP (BELOW 90 DEGREES FAHRENHEIT) UNTIL EXPIRED." 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 USING THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 5.0, LAB: 3.3. TESTS WERE DONE WITHIN AN HOUR OF EACH OTHER. LAB DRAW WAS DONE DUE TO PT'S HIGH INR RESULT. NO UNUSUAL BRUISING/BLEEDING WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1