BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8704885 · Received June 17, 2019

    Report

    Report Number
    1823260-2019-02224
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 27, 2019
    Report Date
    June 17, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. THE REPORTER'S METER AND TEST STRIPS WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED USING RETENTION CONTROLS. TESTING RESULTS (QC RANGE = 2.6 - 4.0 INR): QC 1: 3.0 INR, QC 2: 3.0 INR, QC 3: 3.0 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION MASTER LOT STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. 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. RELEVANT RETENTION TEST STRIPS (LOT 368886) 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.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY USING AN UNKNOWN REAGENT. THE RESULT FROM THE METER WAS 6.0 INR AND THE RESULT FROM THE LABORATORY WAS 3.3 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE PATIENT WAS ANEMIC, BUT THE HEMATOCRIT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497444 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 36888611

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ASPIRIN| CELEXA| CINNAMON| COUMADIN| DIAZEPAM| FENOFIBRATE| LANTUS| LASIX| LEVODOPA| LIPOZENE| LORATADINE| LOVASTATIN| METFORMIN| METOPROLOL| OXYCODONE| VITAMIN D| VITAMIN D| VITAMIN E