BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6944663 · Received October 12, 2017

    Report

    Report Number
    1823260-2017-02290
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 12, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RECEIVED FOR INVESTIGATION AND WAS TESTED WITH MATERLOT STRIPS IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR INR: 3.1 INR AND 2.2 INR, DONOR HCT: 44% AND 56%. TESTING RESULTS: DONOR 1: MASTER LOT / MASTERLOT STRIP AND CUSTOMER METER 3.2 INR/ 3.1 INR. DONOR 2: MASTER LOT / MASTERLOT STRIP AND CUSTOMER METER 2.2 INR/ 2.2 INR. ALL RESULTS WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. NONE OF THE GIVEN TREATMENTS/MEDICATIONS ARE CURRENTLY KNOWN TO INTERFERE WITH THE ACCURACY OF THE TEST RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND STATED THEY RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL (B)(4). THE INITIAL RESULT AT 4:43 PM WAS > 8.0 INR. THE REPEAT RESULT AT 5:12 PM WAS 2.0 INR. THE CUSTOMER BELIEVED THE RESULT OF 2.0 INR WAS CORRECT, BUT REPORTED BOTH RESULTS TO THE DOCTOR. NO CHANGES IN DOSAGE WERE MADE BASED ON THE METER RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER HAD NO HEMATOCRIT ISSUES, TOOK NO OTHER BLOOD THINNERS, AND HAD NO ANTIPHOSPHOLIPID ANTIBODIES. THE THERAPEUTIC RANGE WAS 2-3 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. RELEVANT RETENTION TEST STRIPS (LOT 223855-23) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE ACCEPTABLE AND RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723593 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385523

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR