BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7185756 · Received January 12, 2018

    Report

    Report Number
    1823260-2018-00143
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 26, 2017
    Report Date
    March 19, 2018
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO CUSTOMER MATERIALS WERE RECEIVED FOR INVESTIGATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) FOR ONE PATIENT. THE RESULT FROM THE METER AT 3:11PM WAS 1.2 INR. AT 3:44PM, THE PATIENT WAS TESTED BY A LABORATORY USING THE DADE INNOVIN METHOD AND THE RESULT WAS 1.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. THE CUSTOMER STATED HE DID NOT HAVE ANY STRIPS REMAINING. RELEVANT RETENTION TEST STRIPS (LOT 244031-14) WAS TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29670 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403114

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR