BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8884843 · Received August 12, 2019

    Report

    Report Number
    1823260-2019-02957
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. RELEVANT RETENTION TEST STRIPS (LOT 3973932) 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. THE PATIENT'S METER AND ONE TEST STRIP WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED USING RETENTION CONTROLS. TESTING RESULTS (QC RANGE = 2.8- 4.2 INR): RETURNED STRIP: QC 1: 3.5 INR. RETENTION STRIPS: QC 2: 3.4 INR, QC 3: 3.5 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. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WAS 3%. COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, 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.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT HE RECEIVED DISCREPANT RESULTS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 12:19 P.M., A SAMPLE FROM THIS PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.6 INR. AT 12:22 P.M., A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 4.7 INR. THE PATIENT WAS INSTRUCTED TO SKIP HIS NORMAL 5 MG. DOSE OF WARFARIN BASED ON THIS RESULT. WITHIN 7 HOURS OF BOTH METER TESTS, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 3.1 INR. AT 2:34 P.M. ON (B)(6) 2019, A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING WITH A VALUE OF 3.0 INR. WITHIN 7 HOURS OF THE METER TESTING, A SAMPLE FROM THE PATIENT WAS TESTED IN THE LABORATORY USING AN UNKNOWN METHOD, RESULTING WITH A VALUE OF 2.3 INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE PATIENT'S TESTING FREQUENCY IS ONCE PER WEEK. THE PATIENT HAS BEEN ANEMIC IN THE PAST AND IS NOT CURRENTLY ANEMIC. THE PATIENT IS ON A LOW SODIUM DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678394 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 39739323

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR LEFT VENTRICULAR ASSIST DEVICE| MULTIVITAMIN - (B)(6) BRAND| WARFARIN