BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7048685 · Received November 21, 2017

    Report

    Report Number
    1823260-2017-02707
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 19, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR INR: 2.7 INR AND 2.2 INR. DONOR HCT: 48.5% AND 45%. TESTING RESULTS: DONOR #1: MASTER LOT / CUSTOMER STRIP AND CUSTOMER METER 2.7 INR/ 2.6 INR. DONOR #2: MASTER LOT / CUSTOMER STRIP AND CUSTOMER METER 2.2 INR/ 2.1 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 CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE CUSTOMER STATED HE TESTED HIS MOTHER-IN-LAW AT 7:38 PM AND RECEIVED RESULT OF >8.0 INR. HE THEN TESTED HIMSELF AT 7:41 PM AND RECEIVED A RESULT OF >8.0 INR. HE TESTED HIMSELF A SECOND TIME ON A NEW FINGER ON HIS OWN COAGUCHEK XS METER SERIAL NUMBER (B)(4) AND THE RESULT WAS 2.3 INR WHICH HE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2-3 INR. THE CUSTOMER HAD NO HEMATOCRIT ISSUES, NO ANTIPHOSPHOLIPID ANTIBODIES, NO "OTHER THINNERS", AND NO CHANGES TO DIET, MEDICATION OR LIFESTYLE. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED. REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830959 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385523

    Patients

    Seq Age Sex Outcome Treatment
    1