BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8412128 · Received March 12, 2019

    Report

    Report Number
    1823260-2019-01023
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    November 28, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COUNTRY OF ORIGIN IS (B)(6). OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT INR RESULTS WITH COGUCHEK XS METER SERIAL NUMBER (B)(4) WHEN COMPARED TO A LABORATORY RESULT USING THE HEMO SIL RECOMBIPLASTIN 2G WERFEN METHOD. THE LABORATORY RESULT WAS 4.03 INR AND THE METER RESULTS WERE 7.8 INR AND 7.9 INR. THE PATIENT NOTED THAT NO ADDITIONAL TESTS WERE ABLE TO BE PERFORMED DUE TO THE STRIPS EXPIRING SHORTLY AFTER THE DISCREPANT RESULT. THE PATIENT¿S THERAPEUTIC RANGE IS 3 - 4 INR. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. RELEVANT RETENTION TEST STRIPS (LOT 244031) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT.. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED. COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTINS. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE BASED) ORIGIN ARE NOT A COAGUCHEK SPECIFIC ISSUE. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED AGAINST SEVERAL OTHER (RABBIT, BOVINE-BASED) LABORATORY METHODS. NO PRODUCT IS REQUESTED TO BE RETURNED RELATED TO THIS CASE SINCE THE STRIP LOT IS EXPIRED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205212 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA 244031

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN