BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 2163109 · Received July 15, 2011

    Report

    Report Number
    1823260-2011-03766
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 21, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 2.0 INR ON THE COAGUCHEK XS PLUS SYSTEM WHILE A (B)(4) LAB RETURNED AS 2.86 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20131221

    Patients

    Seq Age Sex Outcome Treatment
    1 089 YR TRIATEC| PACEMAKER| COUMADIN AT MIDNIGHT| UNKNOWN DIGITALIS