BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5627021 · Received May 3, 2016

    Report

    Report Number
    1823260-2016-00575
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 11, 2016
    Report Date
    June 6, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    RELEVANT RETENTION TEST STRIPS (LOT 203360-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230 734 80). THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE RETENTION SAMPLES WERE INCONSPICUOUS. THE CUSTOMER RETURNED THE SUSPECT STRIPS AND THE METER. THE TEST STRIPS AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND CLEAN ON THE OUTSIDE. THE RETURNED METER AND STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. ALL OF THE INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THERE WERE NO ERROR MESSAGES THAT OCCURRED. THE COMPLAINT HAS NOT BEEN SUBSTANTIATED.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE PATIENT HAS BEEN USING HIS COAGUCHEK METER (SERIAL NUMBER UNKNOWN) FOR AT LEAST FOUR YEARS. IT WAS STATED THAT A FEW WEEKS AGO HE WAS STARTING TO GET RESULTS OF 3.0 INR AND LOWER. THE REPORTER STATED THAT THE PATIENT WENT TO THE HOSPITAL AND TESTED AGAINST THEIR COAGUCHEK METER (SERIAL NUMBER UNKNOWN). ACCORDING TO THE PATIENT, THE HOSPITAL STAFF WAS TAKING TWO TESTS FROM ONE FINGERSTICK. THE HOSPITAL STAFF WOULD DOSE FIRST THE PATIENT'S METER AND THEN THE HOSPITAL'S METER. THIS WAS REPEATED WITH A SECOND FINGERSTICK FOR THE SECOND SET OF RESULTS. IT IS NOT STATED AS TO WHETHER OR NOT THAT THE SECOND FINGERSTICK WAS ON THE SAME OR A DIFFERENT FINGER THAN THE FIRST FINGERSTICK. WITH THE FIRST FINGERSTICK, A RESULT OF 3.5 INR WAS OBTAINED ON THE PATIENT'S METER COMPARED TO A RESULT OF 4.0 INR ON THE HOSPITAL METER. WITH THE SECOND FINGERSTICK, A RESULT OF 4.7 INR WAS OBTAINED ON THE PATIENT'S METER COMPARED TO A RESULT OF 4.1 INR ON THE HOSPITAL METER. IT WAS STATED THAT THE PATIENT WAS "NOT ON ANY DRUGS OR HAVE ANY CONDITIONS THAT WOULD AFFECT THE READINGS". THE PATIENT'S THERAPEUTIC RANGE IS 3-4 INR. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281066 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 203360-13

    Patients

    Seq Age Sex Outcome Treatment
    1