BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7493702 · Received May 8, 2018

    Report

    Report Number
    1823260-2018-01408
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 19, 2018
    Report Date
    May 8, 2018
    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

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE INR RESULTS ON THE COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 08:04 AM THE RESULT WAS 2.9 INR WITH THE METER USING A FINGERSTICK. AT APPROXIMATELY 2:00 PM THE RESULT IN THE LABORATORY WAS 5.2 INR WITH A VENOUS BLOOD SAMPLE USING THE DADE INNOVIN METHOD. THE CUSTOMER'S MEDICATION DOSE WAS ADJUSTED BASED ON THE LABORATORY RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AND THE CUSTOMER FEELS FINE. THE THERAPEUTIC RANGE WAS 2.0 - 3.0 INR. THE CUSTOMER WAS NOT ANEMIC, NO HEPARIN, NO ANTIPHOSPHOLIPID ANTIBODIES, AND NO DIRECT THROMBIN INHIBITORS. THE CUSTOMER HAD NO CHANGES IN THEIR WARFARIN DOSE. THE CUSTOMER HAS HAD NO CHANGES IN DIET AND NO SIGNS OF BLEEDING OR BRUISING. THE QC CHECK WAS REVIEWED. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 223855) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339480 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 223855-22

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR ATORDASTATIN| TOPROLOL| WARFARIN