BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE COAGUCHECK XS

    MDR report key: 3202320 · Received June 3, 2013

    Report

    Report Number
    3202320
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT / INR UNIT HAD A HIGH READING IN READING THE INR VALUE. RN REDID THE TEST AND NOTED AN ERROR CODE OF ERROR CODE 6. THE RN REPEATED THE TEST AND RECEIVED ANOTHER ERROR CODE 6. THE RN THEN REPEATED THE TEST A 4TH TIME AND RECEIVED THE ORIGINAL VALUE AS IN TEST 1. GIVEN THE PT WAS PRESENTLY BEING TREATED FOR HIGH VALUES AND WAS NOT PRESENTLY ON WARFARIN, THE VALUE WAS REPORTED TO THE PHYSICIAN. UPON RECEIVING THE NOTIFICATION FROM (B)(4) LABS, WE IMMEDIATELY DID AN IN-SERVICE ON THIS MACHINE AND THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245312 ROCHE COAGUCHECK XS COAGUCHECK XS PT/INR UNIT GJS ROCHE DIAGNOSTICS COAGUCHECK 05005192

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR