BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5545396 · Received April 4, 2016

    Report

    Report Number
    1823260-2016-00407
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 11, 2016
    Report Date
    June 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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE SUSPECT STRIPS AND THE METER. THE TEST STRIPS AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER IN COMPARISON WITH RELEVANT RETENTION TEST STRIPS (LOT 233343-10) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230734-80). THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 0.1 INR. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION. THE COMPLAINT HAS NOT BEEN SUBSTANTIATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A RESULT OF 3.5 INR WAS OBTAINED AT 11:00 AM ON THE COAGUCHEK XS PLUS METER (SERIAL NUMBER UNKNOWN) USING CAPILLARY BLOOD AT THE MEDICAL OFFICE. AT 12:50 PM A RESULT OF 1.5 INR WAS OBTAINED ON THE CUSTOMER'S COAGUCHEK XS METER (SERIAL NUMBER (B)(4)) USING CAPILLARY BLOOD. THE CUSTOMER STATED THE RESULTS WERE PROVIDED TO THE PHYSICIAN. THE CUSTOMER STATED THAT THE RESULTS FROM THE COAGUCHEK XS PLUS AT THE MEDICAL OFFICE WAS THE RESULT THAT WAS BELIEVED TO BE CORRECT. THERE WAS NO ADJUSTMENT TO THE CUSTOMER'S MEDICATION BASED ON EITHER RESULT. IT WAS REPORTED THAT THE PATIENT'S THERAPEUTIC RANGE IS 2.0-2.5 INR. IT WAS STATED THAT HEPARIN WAS NOT INJECTED. THERE WAS NO ADVERSE EVENT. THERE WAS NO OTHER INFORMATION PROVIDED. THE SUSPECT DEVICE WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT. THE RELEVANT RETENTION TEST STRIPS (LOT 233343-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230 734 80). THERE WERE NO ERROR MESSAGES OCCURRED. THE RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201794 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 233343-12

    Patients

    Seq Age Sex Outcome Treatment
    1