BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6214229 · Received December 29, 2016

    Report

    Report Number
    2027969-2016-00710
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Report Date
    November 30, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT K394474 WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. 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

    THE CUSTOMER REPORTED A VARIANCE BETWEEN THE LABORATORY QUICK RESULT OF 40% AND INRATIO QUICK RESULT OF 80%. TIMING BETWEEN TESTS IS UNKNOWN. THE CUSTOMER WAS UNABLE TO PROVIDE ENOUGH INFORMATION TO CONVERT THE QUICK RESULTS INTO INR RESULTS. THERAPEUTIC RANGE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864188 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K394474

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO PT MONITOR, PN 200431, SERIAL# (B)(4)