BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5479831 · Received March 4, 2016

    Report

    Report Number
    1823260-2016-00240
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 6, 2016
    Report Date
    March 25, 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

    NA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE VIAL OF THE SUSPECT STRIPS AND THE COAGUCHEK XS METER (SERIAL NUMBER (B)(4)). 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 200781-10) 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 PERFORM AS SPECIFIED. THERE WAS NO PRODUCT PROBLEM FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A 3.6 INR AND A 2.6 INR ON HIS COAGUCHEK XS (SERIAL NUMBER (B)(4)). THE SAMPLES WERE FROM TWO FINGERS AND THEY WERE TAKEN WITHIN 10 MINUTES. THE CUSTOMER'S THERAPEUTIC RANGE IS 2-3 INR. 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 200781-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230 734 80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE INCONSPICUOUS. THE RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136361 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20078111

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR DIGITOXIN