BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIP

    MDR report key: 5001894 · Received August 13, 2015

    Report

    Report Number
    2027969-2015-00583
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, IN-HOUSE RETAIN TESTING WAS PERFORMED. IN-HOUSE TESTING ON RETAINED STRIP LOT K372403 MET CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A VARIANCE BETWEEN THE INRATIO2 INR RESULT AND THE LABORATORY INR RESULT ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: PATIENT: 9, DATE: (B)(6) 2015, INRATIO2 INR: 1.8, LABORATORY INR: 3.27. THERAPEUTIC RANGE: NOT PROVIDED. THE TIME BETWEEN TESTING WAS TWO (2) MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534958 INRATIO2 PT/INR PROFESSIONAL TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K372403

    Patients

    Seq Age Sex Outcome Treatment
    1