BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8203947 · Received December 28, 2018

    Report

    Report Number
    1823260-2018-05169
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 13, 2018
    Report Date
    December 28, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH INR RESULT FOR 1 PATIENT TESTED ON COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO THE ANAX LABORATORY METHOD. THE RESULT FROM THE METER WAS > 8.0 INR. THE RESULT FROM THE LABORATORY AT THE SAME TIME WAS 5.1 INR. THE LABORATORY RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT'S WARFARIN DOSE WAS HELD BASED ON THE 5.1 INR RESULT. NO OTHER TREATMENT WAS NECESSARY. THE PATIENT'S THERAPEUTIC RANGE IS 2 - 3 INR. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE PATIENT FEELS FINE. THE PATIENT IS NOT ON HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THE PATIENT DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT HAS A YEAST INFECTION. THE PATIENT HAS NOT HAD ANY DIET CHANGES AND NO BLEEDING OR BRUISING. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 345215) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041127 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 34521511

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR