BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 10661406 · Received October 12, 2020

    Report

    Report Number
    1823260-2020-02503
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 10, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VIAL CONTAINING 1 TEST STRIP OF LOT 40501111 WAS RETURNED FOR INVESTIGATION. THE RETURNED TEST STRIP WAS TESTED ON REFERENCE METERS WITH A HIGH LEVEL CONTROL SAMPLE IN COMPARISON TO THE RE-CALIBRATED MASTERLOT ON AN INTERNAL REFERENCE METER: TESTING RESULTS (QC RANGE: 2.6 - 3.2 INR): QC 1: 2.9 INR (CUSTOMER'S TEST STRIP), QC 2: 3.0 INR (RETAINED TEST STRIP), QC 3: 3.0 INR (RETAINED TEST STRIP). THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WAS 11.5 %. THE OBTAINED QC RESULTS WERE IN THE ALLOWED RANGE. NO ERROR MESSAGES OCCURRED DURING THE INVESTIGATION. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). OCCUPATION IS LAY USER/PATIENT. THE CUSTOMER¿S TEST STRIPS WERE REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME AND IS NOT EXPECTED TO BE RETURNED. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT INR RESULTS WITH A COAGUCHEK XS METER COMPARED TO A LABORATORY DESTINY ANALYZER WITH TCOAG TRINICLOT PT REAGENT. THE SERIAL NUMBER OF THE COAGUCHEK XS METER WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2020, (B)(6) 2020, AND (B)(6) 2020, THE CUSTOMER PERFORMED METER TESTING IMMEDIATELY AFTER LABORATORY BLOODWORK WAS COMPLETED. ON (B)(6) 2020 AND (B)(6) 2020, THE CUSTOMER SWITCHED FROM TEST STRIP LOT 4050111 TO TEST STRIP LOT 46588222 FOR METER TESTING. (B)(6) 2020, THE CUSTOMER¿S METER RESULT WAS 2.6 INR, AND THE CUSTOMER¿S LABORATORY RESULT WITHIN FOUR HOURS WAS 1.9 INR. THE CUSTOMER USED TEST STRIP LOT 4050111 FOR METER TESTING. (B)(6) 2020, THE CUSTOMER¿S METER RESULT WAS 2.9 INR, AND THE CUSTOMER¿S LABORATORY RESULT WITHIN FOUR HOURS WAS 2.1 INR. THE CUSTOMER USED TEST STRIP LOT 4050111 FOR METER TESTING. (B)(6) 2020, THE CUSTOMER¿S LABORATORY RESULT WAS 2.7 INR, AND THE CUSTOMER¿S METER RESULT WAS 3.8 INR. THE CUSTOMER USED TEST STRIP LOT 4050111 FOR METER TESTING. (B)(6) 2020, THE CUSTOMER¿S LABORATORY RESULT WAS 3.1 INR, AND THE CUSTOMER¿S METER RESULT WAS 4.6 INR. THE CUSTOMER USED TEST STRIP LOT 46588222 FOR METER TESTING. (B)(6) 2020, THE CUSTOMER¿S LABORATORY RESULT WAS 3.2 INR, AND THE CUSTOMER¿S METER RESULT WAS 4.2 INR. THE CUSTOMER USED TEST STRIP LOT 46588222 FOR METER TESTING. THE CUSTOMER USED THE LABORATORY¿S RESULTS TO ADJUST THE DOSAGE OF MEDICATION. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2.5- 3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129273 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 40501110, 46588222

    Patients

    Seq Age Sex Outcome Treatment
    1 BISOPROLOL| WARFARIN