BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5580598 · Received April 15, 2016

    Report

    Report Number
    1823260-2016-00439
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    March 14, 2016
    Report Date
    June 2, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE SUSPECT STRIPS AND THE METER. THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE COMPLAINT HAS NOT BEEN SUBSTANTIATED.

    Description of Event or Problem · 1

    IT WAS STATED THAT WHILE TESTING ON (B)(6) 2016 THE CUSTOMER OBTAINED A RESULT OF 5.2 INR ON HER COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) WHILE A LABORATORY RESULT DONE WITHIN 7 HOURS FROM HER METER RESULT WAS 3.4 INR. IT WAS REPORTED THAT THE LABORATORY USES THE DADE INNOVIN REAGENT. THE CUSTOMER STATED THAT THERE WAS NO MEDICATION CHANGE OR TREATMENT RECEIVED DUE TO THE READINGS. THE CUSTOMER DOES NOT HAVE POLYCYTHEMIA. SHE DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. SHE IS NOT ON ANY DIRECT THROMBIN INHIBITORS. THERE WAS NO CHANGES IN HER DIET OR MEDICATION. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT. THE RELEVANT RETENTION TEST STRIPS (LOT 200782-21) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236008 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20078221

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR