BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6278980 · Received January 26, 2017

    Report

    Report Number
    1823260-2017-00147
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 14, 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. THE TEST STRIPS WERE NOT RETURNED. BASED ON REVIEW OF THE METER MEMORY, THERE ARE ADDITIONAL ERRONEOUS RESULTS. ON (B)(6) 2015 THERE IS A RESULT OF 2.5 INR AT 1:12 P.M. AND A RESULT OF 1.1 INR AT 1:21 P.M. ON (B)(6) 2015 THERE IS A RESULT OF 2.6 INR AT 2:35 P.M. AND A RESULT OF 1.0 INR AT 2:47 P.M. 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 INR: 2.3 INR, DONOR #2 INR: 2.7 INR. DONOR #1 HCT: 46%, DONOR #2 HCT: 43%. TESTING RESULTS: DONOR #1: MASTERLOT: 2.3 INR, DONOR #1: CUSTOMER'S METER AND MASTERLOT: 2.3 INR. DONOR #2: MASTERLOT: 2.6 INR, DONOR #2: CUSTOMER'S METER AND MASTERLOT: 2.6 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.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS ON HER COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) COMPARED TO THE DOCTOR¿S COAGUCHEK XS METER. THE CUSTOMER TESTED ON HER METER AND THE RESULT WAS 3.7 INR. THIRTY MINUTES LATER, THE CUSTOMER TESTED ON THE DOCTOR¿S COAGUCHEK XS METER AND THE RESULT WAS 1.9 INR. DIFFERENT FINGERS WERE USED FOR EACH TEST. NO MEDICATION CHANGES WERE MADE BASED ON THE CUSTOMER¿S METER. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2-3 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS FEELING OK. THE CUSTOMER IS NOT ANEMIC, IS NOT TAKING HEPARIN OR DIRECT THROMBIN INHIBITORS, AND HAS NO ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER HAS HAD NO CHANGES IN COUMADIN AND NO NEW MEDICATIONS. THE CUSTOMER HAS HAD NO RECENT ILLNESSES AND NO DIET CHANGES. THE CUSTOMER DID NOT HAVE HIGH SYMPTOMS WITH THE RESULT OF 3.7 INR. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. REPLACEMENTS WERE SENT. RELEVANT RETENTION TEST STRIPS (LOT 152881-23) 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. THE RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64506 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 15288123

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR COUMADIN