BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5441204 · Received February 17, 2016

    Report

    Report Number
    1823260-2016-00174
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    February 1, 2016
    Report Date
    April 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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. PRODUCT WAS NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTED STATED THAT WHILE THE PATIENT WAS USING HIS COAGUCHEK XS (SERIAL NUMBER (B)(4)) ON (B)(6) 2016 HE OBTAINED A RESULT OF 2.7 INR AT 9:36 AM COMPARED TO A LABORATORY SAMPLE AT 2:52 PM THAT WAS 2.0 INR. A DADE INNOVIN REAGENT WAS USED FOR THE LABORATORY SAMPLE. HIS COUMADIN DOSE WAS CHANGED BASED ON THE LABORATORY RESULT. THE PATIENT IS PART OF A STUDY DUE TO HIS LVAD. HE TESTS TWICE A WEEK AND IF HIS INR IS BELOW A CERTAIN LEVEL HE WILL RECEIVE HEPARIN AND LOVENOX. HIS INR WAS 1.6 INR PRIOR TO (B)(6) 2016 AND HE RECEIVED HEPARIN ON (B)(6) 2016 AND LOVENOX ON (B)(6) 2016 AND (B)(6) 2016. THE PATIENT'S THERAPEUTIC RANGE IS 2-3 INR. HE DOES NOT HAVE ANY ANTIPHOSPHOLIPID ANTIBODIES. HE IS NOT ON ANY DIRECT THROMBIN INHIBITORS. THE PATIENT IS FEELING FINE. 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. THE RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98182 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23343321

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR