BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7809435 · Received August 23, 2018

    Report

    Report Number
    1823260-2018-02836
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 6, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702128101
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS FOR 1 PATIENT TESTED ON COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO A LABORATORY USING THE DADE INNOVIN METHOD. THE PATIENT HAD BEEN IN THE HOSPITAL DUE TO ENCEPHALOPATHY AND WAS RELEASED ON (B)(6) 2018. HIGH ALCOHOL CONTENT WAS FOUND IN HER BLOOD DURING THAT STAY. THE PATIENT HAD NOT BEEN TAKING COUMADIN SINCE BEING RELEASED ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM DUE TO WEAKNESS AND DEHYDRATION. THE PATIENT WAS CURRENTLY HOSPITALIZED DUE TO CONDITIONS UNRELATED TO THE USE OF THE METER. THE PATIENT WAS EXTREMELY MALNOURISHED DUE TO HER EATING DISORDER. THE INITIAL RESULT FROM THE METER AT 12:45 P.M. WAS 5.5 INR. THE RESULT FROM THE LABORATORY AT 1:45 P.M. WAS 4.2 INR. THE PATIENT'S COUMADIN DOSE WAS HELD BASED ON THE LABORATORY RESULT. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. NO ADVERSE EVENT OCCURRED DUE TO THE DEVICE. THE PATIENT IS NOT ANEMIC AND DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT IS NOT ON HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THE PATIENT HAS BRUISES ON HER ARM WHICH ARE RELATED TO WEAKNESS AND DEHYDRATION AND NOT RELATED TO THE USE OF THE METER. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 223853) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651954 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385315 00365702128101

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR