BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 4102331 · Received September 19, 2014

    Report

    Report Number
    1823260-2014-07193
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER TESTED 6.4 INR, 4.7 INR, 4.4 INR, AND 4.0 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
    584887 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22307421

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR FUROSEMIDE PM| VITAMIN C AM/PM| FINASTERIDE PM| METFORMIN AM/PM| ONETOUCH ULTRA METER| LOVAZA AM/PM| LISINOPRIL PM| LOSARTAN POTASSIUM AM/PM| B-12 AM/PM| CRESTOR PM| AMLODIPINE BESYLATE PM| BABY ASPIRIN| CARVEDILOL AM/PM| HYDRALAZINE AM/PM| GLYBURIDE AM/PM| COUMADIN PM| FENOFIBRATE PM| OMEPRAZOLE AM| JANUVIA PM| LANTUS PM