BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5631322 · Received May 4, 2016

    Report

    Report Number
    2027969-2016-00296
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 21, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    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 OF THE IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370019 MAY RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMERS USE OF AN EXPIRED PRODUCT MAY HAVE CONTRIBUTED TO THE UNEXPECTED RESULT EXPERIENCED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. FURTHER INVESTIGATION PERFORMED UNDER CAPA (B)(4) WHICH WAS INITIATED TO INVESTIGATE THE CAUSE OF HIGHLY DISCREPANT RESULTS.

    Description of Event or Problem · 1

    THE FOLLOWING VARIANCE BETWEEN THE INRATIO2 INR RESULT AND THE LABORATORY INR RESULT WAS REPORTED VIA TELEPHONE CALL ON (B)(6) 2016 ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: (B)(6). REPORTED, THE PATIENT WAS USING EXPIRED TESTING STRIPS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286081 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370019

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN (B)(4)