BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2955558 · Received February 11, 2013

    Report

    Report Number
    1823260-2013-00812
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 3.4 INR ON THE COAGUCHEK XS SYSTEM WHILE A PROFESSIONAL METHOD RETURNED AS 2.6 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59508 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21417213

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR ARTIFICIAL "HEART" VALVE| BISOPROLOL| MARCUMAR