BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIP

    MDR report key: 5538934 · Received March 31, 2016

    Report

    Report Number
    2027969-2016-00200
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    September 30, 2015
    Report Date
    March 7, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE STRIP TESTING ON STRIP LOT K370019 MET CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. IT WAS REPORTED THAT THE CUSTOMER HAD CANCER AND CHRONIC INFLAMMATION. THESE CONDITIONS MAY IMPACT THE PERFORMANCE OF THE ASSAY. A 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 AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, IT WAS REPORTED THAT VARIANCES BETWEEN THE INRATIO2 INR RESULTS AND OTHER INR TESTING METHODS OCCURRED ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: (B)(6). THE TIME BETWEEN TESTING AND THE THERAPEUTIC RANGE WAS UNKNOWN. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193151 INRATIO2 PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370019

    Patients

    Seq Age Sex Outcome Treatment
    1 COAGUCHEK MONITOR AND TESTING STRIPS