BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5623513 · Received May 2, 2016

    Report

    Report Number
    1823260-2016-00558
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Date of Event
    April 12, 2016
    Report Date
    June 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED AS THE CUSTOMER NO LONGER HAD STRIPS TO RETURN FOR INVESTIGATION. THE RETURNED METER WAS TESTED WITH THE CURRENT MASTERLOT OF STRIPS AND THE RETENTION STRIPS FROM THE COMPLAINED LOT. ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETURNED METER AND THE RETENTION MATERIAL MEET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER NO LONGER HAS THE STRIPS USED IN THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT STATES WHILE USING HIS COAGUCHEK XS METER (SERIAL NUMBER (B)(4)), HE OBTAINED A RESULT OF 3.4 INR. WITHIN 35 MINUTES A TEST WAS DONE ON THE DOCTOR'S COAGUCHEK XS PLUS METER (SERIAL NUMBER UNKNOWN) AND THE RESULT ON IT WAS 2.6 INR. HE RETESTED ON HIS METER WITHIN ONE HOUR FROM HIS INITIAL METER RESULT AND OBTAINED A RESULT OF 3.2 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.5-3.5 INR. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED. HOWEVER, THERE WERE NO STRIPS LEFT TO RETURN. THE REPLACEMENT PRODUCT WAS SENT. THE RELEVANT RETENTION TEST STRIPS (LOT 200781-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230 734 80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279359 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 200781-12

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR ACE INHIBITOR