BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7330266 · Received March 12, 2018

    Report

    Report Number
    1823260-2018-00760
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 12, 2018
    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). THE CUSTOMER DID NOT RETURN THE TEST STRIPS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A HIGH ERRONEOUS INR RESULT ON COAGUCHEK XS METER WITH SERIAL (B)(4). THE INITIAL RESULT AT 9:50 A.M. WAS 3.6 INR WITH STRIP LOT 22385522. THE CUSTOMER RE-TESTED WITH A DIFFERENT STRIP LOT 24789623 AT 10:10 A.M. AND THE RESULT WAS 2.4 INR. THE CUSTOMER USED A NEW FINGER FOR EACH TEST. THE CUSTOMER THINKS THE RESULT OF 2.4 INR IS CORRECT. NO CHANGES WERE MADE TO THE CUSTOMER'S DOSAGE AND NO TREATMENT WAS NECESSARY. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0 ¿ 2.5 INR. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS DOING FINE. THE CUSTOMER DOES NOT HAVE ANEMIA OR ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER IS NOT ON HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THERE HAVE BEEN NO CHANGES TO THE CUSTOMER'S COUMADIN DOSE OR DIET. THE CUSTOMER HAS NOT STARTED TAKING ANY NEW MEDICATIONS AND HAS NOT BEEN ILL RECENTLY. THE CUSTOMER HAS NO SIGNS OF BLEEDING OR BRUISING. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 223855-22) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. 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. THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. HUMAN BLOOD SAMPLES FROM WARFARIN DONORS WERE USED. (B)(6). ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET THE SPECIFICATIONS. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173885 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385522

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR