BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5339912 · Received January 4, 2016

    Report

    Report Number
    1823260-2016-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 16, 2015
    Report Date
    March 31, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE VIAL OF STRIPS (LOT NUMBER 200782) WITH 2 PREVIOUSLY INSERTED STRIPS IN IT. THE METER WAS ALSO RETURNED. THE RETURNED METER & MASTERLOT STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. THE RETURNED STRIPS COULD NOT BE USED AS THEY HAD BEEN PREVIOUSLY INSERTED MULTIPLE TIMES. ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THE RELEVANT RETENTION TEST STRIPS (LOT 20078221) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. THE CUSTOMER RETURNED THE VIAL WITH TWO USED STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING RESULTS WERE OBTAINED FROM THE COAGUCHEK XS (SERIAL NUMBER (B)(4)): 2.5 INR AT 3:30 PM AND 2.5 INR AT 4:45 PM (CST). THE DOCTORS METER ,WHICH WAS REPORTED AS THE SAME TYPE OF METER, SHOWED A RESULT OF 4.1 INR AT 11:00 AM ON THE SAME DAY. THE MD STOPPED THE CUSTOMER'S COUMADIN FOR 3 DAYS BASED ON THE READING FROM THE METER AT THE DOCTOR'S OFFICE. THE CUSTOMER IS NOT ON HEPARIN. THE CUSTOMER IS NOT TAKING ANY DIRECT THROMBIN INHIBITORS. THE CUSTOMER DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. THE THERAPEUTIC RANGE FOR THE CUSTOMER IS 2.0-3.0 INR. THERE WAS NO REPORT OF ANY SPECIAL OR UNUSUAL DIET. THE CUSTOMER IS STABLE. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20078221

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR NIFEDIPINE