BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5930207 · Received September 6, 2016

    Report

    Report Number
    1823260-2016-01315
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    July 18, 2016
    Report Date
    September 9, 2016
    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

    A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE TEST STRIPS WERE NOT RETURNED FOR INVESTIGATION. THE CUSTOMER RETURNED THE METER. THE RETURNED METER WAS MEASURED WITH MASTERLOT STRIPS IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETURNED AND RETENTION MATERIAL WERE WITHIN SPECIFICATION. THERE WAS NO PRODUCT PROBLEM FOUND. THE CUSTOMER DID NOT RETURN THE STRIPS.

    Description of Event or Problem · 1

    ORIGINALLY THE CUSTOMER CALLED REGARDING THE DIFFERENCE OF THE INFORMATION DISPLAYED IN THE METER MEMORY WHEN LOOKING AT TWO DIFFERENT METERS. THE CUSTOMER THEN STATED THAT QUESTIONABLE RESULTS WERE RECEIVED WITH TWO PATIENT'S WHILE USING THEIR COAGUCHEK XS METER (SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THAT THE LABORATORY COMPARISONS WERE DONE USING THE DADE INNOVIN REAGENT. LIQUID CONTROLS ARE RUN EVERY MONDAY AND HAVE BEEN PASSING. FOR PATIENT 1, A METER RESULT OF 5.6 INR WAS OBTAINED AT 9:02 AM ON (B)(6) 2016 COMPARED TO A LABORATORY RESULT OF 3.4 INR ON THE SAME DAY. IT WAS STATED THAT THE TESTS WERE WITHIN 7 HOURS. FOR PATIENT 2, A METER RESULT OF 6.5 INR WAS OBTAINED AT 10:20 AM ON (B)(6) 2016 COMPARED TO A LABORATORY RESULT OF 3.2 INR ON THE SAME DAY. THESE TESTS WERE WITHIN 7 HOURS. THE SECOND PATIENT IS A (B)(6) FEMALE WHOSE DATE OF BIRTH IS (B)(6). THE CUSTOMER BELIEVED THAT THE LABORATORY RESULTS WERE THE CORRECT RESULT FOR BOTH PATIENTS. NEITHER PATIENT HAD ANY TREATMENT OR MEDICATION CHANGES BASED ON THE METER RESULTS. THE CUSTOMER DECLINED TO PROVIDE ANY MEDICATIONS EXCEPT COUMADIN FOR EITHER PATIENT. THE CUSTOMER STATED THAT NEITHER PATIENT HAS ANTIPHOSPHOLIPID ANTIBODIES. THEY WERE BOTH NOT ON HEPARIN OR DIRECT THROMBIN INHIBITORS. NO NEW MEDICATIONS OR RECENT DIETARY CHANGES FOR EITHER PATIENT. THE PATIENTS HAVE NOT HAD DIET CHANGES, ILLNESS, OR SYMPTOMS OF BLEEDING OR BRUISING. THE THERAPEUTIC RANGE IS NOT KNOWN FOR EITHER PATIENT. BOTH PATIENTS GET TESTED ABOUT EVERY TWO WEEKS. IT WAS STATED THAT BOTH PATIENTS WERE STABLE. THERE WERE NO ADVERSE EVENTS. THE CUSTOMER STATED THAT BOTH PATIENTS WERE TESTED USING THE SAME BOTTLE OF STRIPS. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT. THE RELEVANT RETENTION TEST STRIPS (LOT 205402-11) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581119 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20540211

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PATIENT 1 - COUMADIN| PATIENT 2 - COUMADIN