BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR PRO MONITOR REPL

    MDR report key: 3349512 · Received August 12, 2013

    Report

    Report Number
    2027969-2013-00684
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE CASE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF A DISPLAY ISSUE WAS REPLICATED DURING IN-HOUSE INVESTIGATION. INR READINGS FROM THE LCD WERE MISSING THE DECIMAL POINT FROM THE INR RESULT. THE FUNCTION OF THE MONITOR WAS NOT AFFECTED BY THE DISPLAY ISSUE. THE MONITOR WAS SENT TO THE VENDOR, HTI, FOR IN-DEPTH INVESTIGATION AND AS A RESULT, HTI INITIATED A SUPPLIER CORRECTIVE ACTION TO ADDRESS THE ISSUE. THIS INSTRUMENT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS THAT WERE IMPLEMENTED.

    Description of Event or Problem · 1

    CALLER ALLEGED THAT THE INRATIO2 METER SCREEN WAS MISSING THE DECIMAL POINT FOR THE INR RESULTS, WHEN REVIEWING PAST RESULTS ON THE METER. NO FALSE READING OCCURRED DUE TO THE DISPLAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385268 INRATIO2 PT/INR PRO MONITOR REPL PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 55131

    Patients

    Seq Age Sex Outcome Treatment
    1