BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5843115 · Received August 3, 2016

    Report

    Report Number
    1823260-2016-01107
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 3, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SUSPECT PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS WHEN COMPARING THEIR COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) TO A COAGUCHEK XS PLUS METER USED IN THE SURGERY AREA OF A FACILITY. IT WAS NOTED THAT 2 DIFFERENT VIALS OF STRIPS WERE USED ON EACH METER. THE INITIAL RESULT FROM THE COAGUCHEK XS PLUS METER WAS 2.2 INR. THE CUSTOMER TESTED ON THEIR COAGUCHEK XS METER 1-2 HOURS LATER AND OBTAINED A RESULT OF 3.2 INR. IT WAS NOTED THAT THE CUSTOMER'S METER MEMORY SHOWS A RESULT OF 3.3 INR ON THE DAY OF THE EVENT. THE CUSTOMER (B)(4) ;THERAPEUTIC RANGE IS 2.5-3.5 INR. NO ADVERSE EVENT OCCURRED. THE SUSPECT PRODUCT WAS REQUESTED FOR INVESTIGATION. THE LOT NUMBER USED BY THE CUSTOMER WAS NOT PROVIDED. RETENTION TEST STRIPS (LOT 200781-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 23073480). NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL COMPLIES WITH SPECIFICATION. THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS MEASURED WITH RETENTION TEST STRIPS (LOT 200781-10) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496773 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1