BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 2121102 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03199
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 2.9 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.2 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT 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 20131222

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR FUROSEMIDE DAILY| LISINOPRIL| PROTONIX| CALCIUM| SIMVASTATIN| TRAVATAN EYE DROPS| ATENOLOL| "GELATIN" DAILY| AMLODIPINE| AORTIC VALVE REPLACEMENT| WARFARIN| DORZOLAMIDE/TIMOLOL| OCUVITE PRESERVISION| POTASSIUM CHLORIDE ER DAILY| VITAMIN D3| FERROUS SULFATE| CLONIDINE| COLACE| ISOSORBIDE MONONITRATE