BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2020155 · Received March 16, 2011

    Report

    Report Number
    1823260-2011-01423
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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 TESTED 5.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.6 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM HOWEVER CALLER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20030612

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR CALCIUM PLUS VITAMIN D| MECHANICAL "VALVE"| MULTIVITAMIN| ALENDRONATE| SYNTHROID| ASAPHEN| GLUCOSAMINE SULPHATE| COUMADIN| VENTOLIN| CORDARONE| SYMBICORT| VERAPAMIL