BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6192669 · Received December 21, 2016

    Report

    Report Number
    1823260-2016-02029
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 7, 2016
    Report Date
    January 6, 2017
    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).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER AND TEST STRIPS. THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER & MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR #1 HCT: 42%, DONOR #2 HCT: 47%. DONOR #1 MASTER LOT: 2.4 INR, DONOR #1 CUSTOMER'S STRIPS AND CUSTOMER'S METER: 2.5 INR. DONOR #2 MASTER LOT: 3.8 INR, DONOR #2 CUSTOMER'S STRIPS AND CUSTOMER'S METER: 3.8 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. 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 WAS ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS ON HIS COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) WHEN COMPARED TO THE LABORATORY USING THE DADE INNOVIN METHOD. THE CUSTOMER TESTED ON HIS METER AT EITHER 10:31 A.M. OR 11:31 A.M. AND OBTAINED A RESULT OF 2.6 INR. THE QC CHECK MARK WAS OBSERVED FOR THIS TEST. THE CUSTOMER WAS TESTED "WITHIN MINUTES" ON THE DOCTOR¿S NON-ROCHE METER AND THE RESULT WAS 3.8 INR. THE CUSTOMER HAD A RESULT OF 3.5 INR FROM THE LABORATORY USING THE DADE INNOVIN METHOD. THE SAMPLE WAS OBTAINED "WITHIN MINUTES" OF THE FINGER STICK RESULT FROM THE CUSTOMER¿S METER. THE DOCTOR ADJUSTED THE CUSTOMER¿S WARFARIN DOSE BASED ON THE 3.5 INR RESULT FROM THE LABORATORY. THE CUSTOMER HAD BEEN ADVISED TO NOT TAKE WARFARIN FOR 1 DAY BASED ON A RESULT OF 4.3 INR FROM THE LABORATORY ON (B)(6) 2016. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2-3 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS FEELING FINE. THE CUSTOMER IS NOT ON HEPARIN OR DIRECT THROMBIN INHIBITORS. THE CUSTOMER HAS NO ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER IS NOT TAKING ANY NEW MEDICATIONS AND HAS HAD NO CHANGES IN DIET. THE CUSTOMER HAS HAD NO ADDITIONAL ILLNESSES AND IS NOT EXPERIENCING ANY BLEEDING OR BRUISING. THE METER AND STRIPS WERE REQUESTED FOR INVESTIGATION. REPLACEMENTS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843987 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 12804321

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR WARFARIN