BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8883353 · Received August 12, 2019

    Report

    Report Number
    1823260-2019-02936
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 12, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    RES Z-0360-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED TEST STRIPS HAVE BEEN CALIBRATED AGAINST THE WHO STANDARD AND ARE IN THE SCOPE OF THE ROCHE INITIATED RECALL. FOR THESE TEST STRIPS, THERE IS A POTENTIAL FOR A PRODUCT PROBLEM WHEN THE INR IS > 4.5. VALUES > 4.5 INR SHOWED AN INCREASING POSITIVE BIAS. THE INFORMATION IN THE CASE IS CONSISTENT WITH THE DETAILS OF THE RECALL AND THE ISSUE HAS BEEN FULLY INVESTIGATED. 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. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE EVENT OCCURRED IN (B)(6). OCCUPATION - THE OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE INR RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO THE LABORATORY. THE LABORATORY METHOD WAS ASKED FOR BUT NOT PROVIDED. THE RESULT FROM THE LABORATORY WITH VENOUS BLOOD WAS 4.03 INR. THE RESULT FROM THE METER WITH CAPILLARY BLOOD WAS 5.6 INR. THE RESULTS WERE WITHIN 7 HOURS. THE CUSTOMER'S THERAPEUTIC RANGE WAS 2.0 - 3.0 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678718 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 330462-12

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR ANTICOAGULANT| TILIDIN COMP AL