BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7966100 · Received October 15, 2018

    Report

    Report Number
    1823260-2018-03676
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 25, 2018
    Report Date
    January 16, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. RELEVANT RETENTION TEST STRIPS (LOT 244033) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. 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. RETENTION MATERIAL COMPLIES WITH THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT TESTED WITH COAGUCHEK XS PRO METER SERIAL NUMBER (B)(4). THE CUSTOMER NOTED THAT THEY HAD ISSUES WITH RESULTS FROM OTHER PATIENTS, BUT PROVIDED NO DETAILS. A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 3.9 INR. ON THE SAME DAY AT AN UNKNOWN TIME, A SAMPLE FROM THE PATIENT WAS TESTED AT A LABORATORY USING AN UNKNOWN METHOD, RESULTING AS 2.8 INR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS 2 - 3 INR. THE PATIENT'S TESTING FREQUENCY IS ONCE PER MONTH. THE PATIENT'S WARFARIN DOSE HAS BEEN CONSTANT. THE CUSTOMER'S PRODUCT WAS REQUESTED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808118 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403317

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN