BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6928006 · Received October 9, 2017

    Report

    Report Number
    1823260-2017-02217
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 19, 2017
    Report Date
    October 9, 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).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS SERIAL NUMBER (B)(4). THE INITIAL RESULT AT 9:15 AM WAS 4.1 INR AND THE REPEAT RESULT WAS 2.9 INR. ANOTHER TEST PERFORMED AT 11:00 AM WITH TEST STRIP LOT 22385523 HAD A RESULT OF 4.3 INR. THE CUSTOMER REPORTED ALL OF THE RESULTS TO THE DOCTOR AND NONE WERE TRUSTED DUE TO DIFFERENCE. A VENIPUNCTURE WAS THEN PERFORMED AT 1:00 PM AND THE RESULT WAS 3.4 INR. THE REAGENT USED BY THE LABORATORY WAS NOT KNOWN. THE CUSTOMER WAS NOT TREATED BASED ON THE METER RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER HAD NO KNOWN ANEMIA, POLYCYTHEMIA, HEPARINS, ANTIPHOSPHOLIPID ANTIBODIES, OR OTHER ANTICOAGULANTS. THE THERAPEUTIC RANGE WAS 2.0-3.0 INR. THE RETURNED METER AND STRIPS FROM LOT 22385523 WERE RECEIVED FOR INVESTIGATION. THEY 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: 2.2 INR AND 2.5 INR . DONOR HCT: 52% AND 49%. TESTING RESULTS: DONOR 1: MASTER LOT / CUSTOMER STRIP AND METER, 2.3 INR/ 2.3 INR. DONOR 2: MASTER LOT / CUSTOMER STRIP AND METER, 2.5 INR/ 2.5 INR. ALL RESULTS WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MET THE SPECIFICATION. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY. 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
    709920 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 19449123

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR