BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6178241 · Received December 15, 2016

    Report

    Report Number
    1823260-2016-01968
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 26, 2016
    Report Date
    April 4, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER WITH SERIAL NUMBER (B)(4). THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS MEASURED WITH MASTER LOT STRIPS 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: 2.1 INR. DONOR #2: 2.6 INR. DONOR #1 HCT: 44%. DONOR #2 HCT: 48%. DONOR #1: MASTER LOT: 2.2 INR. DONOR #1: CUSTOMER'S METER AND MASTER LOT: 2.1 INR. DONOR #2: MASTER LOT: 2.6 INR. DONOR #2: CUSTOMER'S METER AND MASTER LOT: 2.7 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

    THE CUSTOMER HAS NOT RETURNED ANY PRODUCT. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE DISCREPANT RESULTS. SINCE NO PRODUCT WAS RETURNED, THE INVESTIGATION COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS WHEN COMPARING HER COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) TO THE LABORATORY USING THE DADE INNOVIN METHOD. THE CUSTOMER TESTED ON HER METER AND OBTAINED A RESULT OF 1.8 INR. THE RESULT FROM THE LABORATORY 4 HOURS LATER WAS 1.3 INR. ON (B)(6) 2016 THE CUSTOMER TESTED ON HER METER AND OBTAINED A RESULT OF 4.7 INR. THE RESULT FROM THE LABORATORY 4 HOURS LATER WAS 3.6 INR. THE CUSTOMER¿S DOCTOR CHANGED HER WARFARIN DOSE TO 12.5 MG BASED ON A RESULT FROM THE LABORATORY. SHE DOES NOT KNOW WHAT LABORATORY RESULT WAS USED FOR THIS CHANGE. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2-3 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS FINE. THE CUSTOMER IS NOT ANEMIC. THE METER AND STRIPS WERE REQUESTED FOR INVESTIGATION. REPLACEMENTS WERE SENT. RELEVANT RETENTION TEST STRIPS (LOT 203038) 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 SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827317 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20303812

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR WARFARIN