BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6064503 · Received October 28, 2016

    Report

    Report Number
    1823260-2016-01672
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 23, 2016
    Report Date
    November 22, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE TEST STRIPS. THE METER WAS NOT RETURNED. THE RETURNED STRIPS AND RETENTION METER WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR #1: MASTER LOT: 2.7 INR. DONOR #1: CUSTOMER STRIP AND RETENTION METER: 2.7 INR. DONOR #2: MASTER LOT: 2.6 INR. DONOR #2: CUSTOMER STRIP AND RETENTION METER: 2.4 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER COMPLAINED OF ERRONEOUS INR RESULTS WHEN HER MOTHER TESTED ON HER COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4). THE CUSTOMER TESTED ON HER METER AT 7:56 AM AND OBTAINED AN INR RESULT 2.4 INR. THIRTY MINUTES LATER THE RESULT FROM THE LABORATORY USING THE DADE INNOVIN METHOD WAS 1.9 INR. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THE DOCTOR MADE NO CHANGES TO THE CUSTOMER'S WARFARIN/COUMADIN DOSE. THE CUSTOMER'S THERAPEUTIC RANGE IS 2-3 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS "FEELING AS WELL AS CAN BE EXPECTED." THE CUSTOMER DOES NOT HAVE ANEMIA OR POLYCYTHEMIA. THE CUSTOMER DOES NOT TAKE ANY HEPARIN OR DIRECT THROMBIN INHIBITORS. THE CUSTOMER DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE METER AND TEST STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 128043-21) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL PERFORMED WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714782 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 12804321

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN/COUMADIN