BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6301006 · Received February 3, 2017

    Report

    Report Number
    1823260-2017-00215
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 17, 2017
    Report Date
    February 10, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE TEST STRIPS. THE RETURNED STRIPS AND RETENTION METER WERE TESTED 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: 4.3; DONOR #2 INR: 2.4. DONOR #1 HCT: 30%; DONOR #2 HCT: 47%. DONOR #1: MASTER LOT: 4.2 INR; DONOR #1: CUSTOMER'S STRIPS AND RETENTION METER: 4.3 INR. DONOR #2: MASTER LOT: 2.4 INR; DONOR #2: CUSTOMER'S STRIPS AND RETENTION METER: 2.4 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

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS FOR 1 PATIENT DURING A 6 MONTH CORRELATION STUDY ON THE COAGUCHEK XS PRO METER WITH SERIAL NUMBER (B)(4). THE METER HAD ALREADY BEEN IN SERVICE AT THE TIME OF THE CORRELATION STUDY. THE PATIENT WAS TESTED BY A FINGER STICK ON THE METER AT 12:00 P.M. AND THE RESULT WAS 5.0 INR. THE PATIENT WAS THEN DRAWN FOR THE LABORATORY "RIGHT AWAY." THE RESULT FROM THE LABORATORY ON A SIEMENS ANALYZER USING THE DADE INNOVIN METHOD WAS 3.87 INR. THEY REPEATED THE SAMPLE "RIGHT AWAY" ON ANOTHER SIEMENS ANALYZER USING THE DADE INNOVIN METHOD AND THE RESULT WAS 3.84 INR. THE CUSTOMER THINKS THE RESULTS FROM THE ANALYZERS ARE CORRECT. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0-3.0 INR. NO ADVERSE EVENT OCCURRED. QUALITY CONTROLS WERE RUN ON THE DAY OF THE EVENT AND WERE WITHIN THE APPROPRIATE RANGE. THE PATIENT DOES NOT HAVE HCT ISSUES. THE CUSTOMER DOES NOT THINK THAT THE PATIENT SUFFERS FROM ANTIPHOSPHOLIPID ANTIBODIES. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 121350) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83499 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 12135012

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN