BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5900965 · Received August 24, 2016

    Report

    Report Number
    2027969-2016-00588
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 2, 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

    THE CUSTOMER DID NOT PROVIDE A COMPARATIVE FOR THE REPORTED INRATIO VALUES. IT IS NOT POSSIBLE TO VERIFY IF A DISCREPANCY EXISTS WITHOUT THIS INFORMATION. IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN HOUSE TESTING ON RETAINED STRIP LOT K384107 MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    A VARIANCE WAS REPORTED BETWEEN INRATIO RESULTS OCCURRING ON TWO CONSECUTIVE DAYS. THE RESULTS WERE AS FOLLOWS: INRATIO ((B)(6) 2016): INR 3.1. INRATIO ((B)(6) 2016): INR 1.5. THE CUSTOMER STATED THAT THERE WERE OTHER VARIABLE RESULTS BUT DID NOT RECALL DETAILS SUCH AS DATES AND RESULTS. NO THERAPEUTIC RANGE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551864 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K384107

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR INRATIO MONITOR SN: (B)(4)