BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3862867 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00142
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 31, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. A REVIEW OF THE BATCH RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. RESULTS OF THE QUERY OF SIMILAR INCIDENT IN THE COMPLAINT SYSTEM FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT LOW INRATIO VALUE. DATE: (B)(6) 2014, INRATIO: 1.6, LAB: 2.0. ONE HOUR BETWEEN TESTING. PATIENT'S THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104353 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329655

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 8MG 3 DAYS A WEEK, 6MG ON REMAINING DAYS