BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 5952232 · Received September 15, 2016

    Report

    Report Number
    1823260-2016-01381
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 25, 2016
    Report Date
    December 12, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION WAS PERFORMED ON THE RETURNED METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS MEASURED WITH THE RELEVANT RETENTION TEST STRIPS (LOT 121353-10) AND THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR #1 WITH THE MASTER LOT STRIPS AND RETENTION METER: 2.2 INR. DONOR #1 WITH THE RETENTION STRIPS AND CUSTOMER METER: 2.3 INR. DONOR #2 WITH THE MASTER LOT STRIPS AND RETENTION METER: 2.5 INR. DONOR #2 WITH THE RETENTION STRIPS AND CUSTOMER METER: 2.6 INR. THE RETURNED CUSTOMER MATERIAL AND THE RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS TESTED WITH RETENTION STRIPS USING CONTROLS. CONTROL SAMPLE LOT 10005250, SPECIFIED TARGET RANGE 2.1-3.3 INR, CONTROL SAMPLE LOT 10006065, SPECIFIED TARGET RANGE 1.5-2.3 INR. RETENTION STRIPS TESTED WITH CUSTOMER METER GAVE THE FOLLOWING RESULTS: CONTROL SAMPLE LOT 10005050 2.7 INR, CONTROL SAMPLE LOT 10006065 1.9 INR. ALL INR CONTROL VALUES WERE WITHIN THE SPECIFIED RANGES. NO ERROR MESSAGES OCCURRED. THE RETURNED METER AND RETENTION MATERIAL MEETS SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED ON COAGUCHEK XS PLUS METER WITH SERIAL NUMBER (B)(4). THE RESULT FROM THE METER WAS 1.8 INR. A SAMPLE WAS TAKEN FOR THE LABORATORY AT THE SAME TIME. THE RESULT FROM THE LABORATORY USING THE DADE INNOVIN METHOD WAS 2.3 INR. THE PATIENT WAS AT THE GENERAL PRACTITIONER'S OFFICE FOR SURGERY. THE PATIENT'S THERAPEUTIC RANGE IS 2-3 INR. NO ADVERSE EVENT OCCURRED. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 121353-10) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124 158 80). FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION STRIPS/RETENTION METER MASTER LOT /RETENTION METER DONOR 1: 2.2 INR AND 2.1 INR; DONOR 2: 2.3 INR AND 2.2 INR. THE RESULTS OBTAINED SHOWED A MAXIMUM DIFFERENCE OF 0.1 INR BETWEEN RETENTION SAMPLES AND THE MASTER LOT. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE INCONSPICUOUS. THE RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604941 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 121353-11

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN