BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1902269 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06816
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 19, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 3.5 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.2 INR. PATIENT WAS GIVEN AN EXTRA DOSE OF COUMADIN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL DUE TO RESPIRATORY DISTRESS. WHILE IN THE HOSPITAL, IT WAS NOTED THAT THE PT HAD PULSATILE FLOW AND WIDE PULSE PRESSURE. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED WHICH SHOWED THAT THE LEFT VENTRICLE (LV)/ RIGHT VENTRICLE (RV) WERE DILATED AND THE AORTIC VALVE APPEARED TO BE OPENING WITH EVERY BEAT WITH MINIMAL CHANGE ON THE LV DESPITE INCREASING THE PUMP SPEED. THE HOSPITAL MADE A DECISION TO EXCHANGE THE LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20177321

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR COUMADIN| LASIX| "IRON" PILL| "ESTROGEN" PILLS| "HEART VALVE"