BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 3170306 · Received June 14, 2013

    Report

    Report Number
    1823260-2013-03601
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.

    Description of Event or Problem · 1

    REPORTER STATED THAT A PATIENT CAPILLARY SAMPLE WAS TESTED ON THE COAGUCHEK XS SYSTEM, AT 9:56 AM, WITH A RESULT OF 4.0 INR. AT 10:01 AM, AN ADDITIONAL SAMPLE OBTAINED FROM PATIENT (SAMPLE TYPE NOT REPORTED) MEASURED 2.8 INR ON A STAGO LABORATORY INSTRUMENT. NO MODIFICATION TO PATIENT THERAPY WAS REPORTED AND NO ADVERSE EVENT OCCURRED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270916 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 21815511

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR VITAMIN C| VITAMIN D3| PRILOSEC| TOPROL XL| MECLIZINE| WARFARIN| GLUCOSAMINE| OCUVITE