BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2083071 · Received May 10, 2011

    Report

    Report Number
    1823260-2011-02484
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.0 INR ON THE COAGUCHEK XS SYSTEM AND 5.0 INR ON A COMPARISON LAB. CALLER STATES THE COUMADIN WAS HELD BASED ON THE LAB RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20180332

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN