BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1852232 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05855
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 2.1 INR, 2.1 INR, 1.7 INR AND 1.5 INR ON THE COAGUCHEK XS SYSTEM. NO 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 20181231

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR BLOOD PRESSURE UNIT| SERTRALINE| PLAVIX| PULMICORT| ALBUTEROL| SINGULAIR| PROTONIX| FERROUS SULFATE| ADVAIR| LANTUS| LASIX| NEBULIZER| POTASSIUM| COUMADIN| WALKER| AMIODARONE| PREDNISONE| ALLOPURINOL