BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5295518 · Received December 14, 2015

    Report

    Report Number
    1823260-2015-06030
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 18, 2015
    Report Date
    December 14, 2015
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VALUE OF 2.2 INR WAS OBTAINED ON THE COAGUCHEK XS (SERIAL NUMBER (B)(4)) AND A SECOND COAGUCHEK XS (SERIAL NUMBER NOT PROVIDED) ALSO OBTAINED A RESULT OF 2.2 INR. A LAB WAS DRAWN AND USING DADE INNOVIN REAGENT A RESULT OF 1.68 INR WAS OBTAINED. IT WAS REPORTED THAT BOTH STRIPS 233339-12 AND 233432-11 WERE USED BUT IT IS NOT KNOWN WHICH STRIP LOT WAS USED WITH WHICH METER. THERE IS NO INFORMATION PROVIDED REGARDING HER HEMATOCRIT OR THERAPEUTIC RANGE. THERE WAS NO ADVERSE EVENT. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED AND THE CUSTOMER REFUSED TO SEND IT BACK. PLEASE REFER TO MEDWATCH WITH (B)(6) FOR STRIP LOT NUMBER 23334211. RELEVANT RETENTION TEST STRIPS (LOT 233339-10 AND 233342-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 230 734 80). THE OBTAINED RESULTS SHOWED A MAXIMUM DIFFERENCE OF 0.1 INR BETWEEN RETENTION SAMPLES AND MASTER LOT. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLE TESTING DID NOT IDENTIFY AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823325 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 23333912

    Patients

    Seq Age Sex Outcome Treatment
    1 31