BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4860003 · Received June 22, 2015

    Report

    Report Number
    1823260-2015-03694
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 27, 2015
    Report Date
    July 6, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT TESTED 5.3 INR AND 2.9 INR ON THE COAGUCHEK XS SYSTEM. NO ACTIONS TAKEN BASED ON THE DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404267 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23194922

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR VITAMIN B| ATORVASTATIN| MULTIVITAMIN| LANTUS| AMLODIPINE| VITAMIN D| GLIPIZIDE| FOLIC ACID| VITAMIN C| CARVEDILOL| WARFARIN| TRAVOPROST| "TIMOLOG"| NITROGLYCERIN| NOVOLOG| ASPIRIN| FUROSEMIDE| LORSARTAN