BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3894170 · Received February 13, 2014

    Report

    Report Number
    2027969-2014-00118
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INCIDENTS IN THE COMPLAINT SYSTEM FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. 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 ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 3.9 VS 1.7 VS 1.1. TESTS WERE PERFORMED WITHIN THIRTY MINUTES. THE FIRST TWO TESTS WERE DONE USING THE SAME FINGER. THERAPEUTIC RANGE 2-3. IT WAS NOTED THAT THE STRIPS WERE STORED IN THE BASEMENT AND MIGHT HAVE REACHED TEMPERATURES BELOW 34 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95601 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 301621

    Patients

    Seq Age Sex Outcome Treatment
    1 OXYCODONE| WARFARIN