BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5567196 · Received April 11, 2016

    Report

    Report Number
    1823260-2016-00422
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    March 24, 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

    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

    THE CUSTOMER STATED THAT HIS METER IS READING HIGHER THAN A DOCTOR'S COAGUCHEK METER (SERIAL NUMBER UNKNOWN). THE CUSTOMER DOES NOT HAVE ANY OTHER INFORMATION REGARDING THE DOCTOR'S METER OR THE STRIPS FROM THAT DEVICE. HE STATED THAT HE OBTAINED A READING OF 2.8 INR ON HIS COAGUCHEK XS PLUS METER (SERIAL NUMBER (B)(4)) AND A READING OF 2.0 INR ON THE DOCTOR'S METER. A NEW FINGERSTICK ON A NEW FINGER WAS USED FOR EACH TEST. HE REPORTED THAT THE TESTS WERE MINUTES APART. HE STATED HIS COUMADIN DOSE WAS NOT CHANGED BECAUSE OF THE READINGS. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0-3.0 INR. THE CUSTOMER IS NOT ON HEPARIN OF ANY DIRECT THROMBIN INHIBITORS. HE DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER WAS FEELING OKAY AT THE TIME HE CALLED. 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 233433) 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
    222324 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23343321

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR