BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5483029 · Received March 7, 2016

    Report

    Report Number
    1823260-2016-00248
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Date of Event
    February 15, 2016
    Report Date
    March 7, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE IS CALLING FOR THE CUSTOMER. THE NURSE STATED THAT THE CUSTOMER OBTAINED A RESULT OF 2.6 INR AT 1:26 PM ON HIS COAGUCHEK XS (SERIAL NUMBER (B)(4)) WHILE A LABORATORY SAMPLE DRAWN AT 2:49 PM WAS 1.8 INR. IT WAS REPORTED THAT THE CUSTOMER'S WARFARIN DOSE WAS INCREASED TO 6.5 MG FOR ONE DAY BASED ON THE LABORATORY RESULT. THE CUSTOMER'S THERAPEUTIC RANGE IS 2-3 INR. THE NURSE REPORTED THAT THE CUSTOMER DID NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. THE NURSE STATED THAT HE WAS NOT ON HEPARIN OR ANY DIRECT THROMBIN INHIBITORS. THE NURSE STATED THAT THE CUSTOMER WAS IN GOOD CONDITION. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT. THE CUSTOMER RETURNED THE VIAL OF STRIPS WITH ONE TEST STRIP LEFT IN IT. THE TEST STRIP, VIAL AND STOPPER SHOWED NO NOTICEABLE DEFECTS. FOR TESTING THE ONE STRIP IN THE RETURNED VIAL AND A RETENTION STRIP WAS USED. THE RELEVANT RETENTION TEST STRIPS (LOT 233433) WERE ALSO TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WAS NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE ACCEPTABLE. THE CUSTOMER ALLEGATION COULD NOT BE SUBSTANTIATED. THERE WAS NO PRODUCT PROBLEM FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139841 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23343321

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR WARFARIN