BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8105664 · Received November 27, 2018

    Report

    Report Number
    1823260-2018-04496
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    October 10, 2018
    Report Date
    February 6, 2019
    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 · 0

    THE TEST STRIPS RETURNED BY THE CUSTOMER WERE STORED OUTSIDE THE STRIP VIAL, SO THEY WERE UNSUITABLE FOR TESTING. RELEVANT RETENTION TEST STRIPS (LOT 223853) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT (ML 13 #286321-80 RECAL. RTF/09). FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED.

    Additional Manufacturer Narrative · 1

    COUNTRY OF ORIGIN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A DISCREPANT INR READING BETWEEN HIS COAGUCHEK XS METER SERIAL NUMBER (B)(4), AND DOCTOR'S OFFICE COAGUCHEK METER WITH AN UNKNOWN SERIAL NUMBER. THE READINGS WERE OBTAINED AT THE SAME TIME. ON THE CUSTOMER METER THE RESULT WAS 1.9 INR AND ON THE PROFESSIONAL METER THE RESULT WAS 2.6 INR. THE CUSTOMER¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER IS 'VERY STABLE IN RANGE AND IS SELF-DOSING HIS WARFARIN AS AGREED WITH CLINIC.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946494 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385313

    Patients

    Seq Age Sex Outcome Treatment
    1 PILLS FOR HIGH BLOOD PRESSURE| WARFARIN