BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7174553 · Received January 9, 2018

    Report

    Report Number
    1823260-2018-00088
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 25, 2017
    Report Date
    February 26, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AS NO CUSTOMER MATERIAL WAS RECEIVED, THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). ON (B)(6) 2017 AT 2:15 AM, THE RESULT WAS 2.5 INR. ON (B)(6) 2017 AT 2:48 AM, THE RESULT WAS 4.8 INR. AT 2:56 AM, THE RESULT WAS 2.4 INR. AT 3:00 AM, THE RESULT WAS 2.2 INR. AT 3:17 AM, THE RESULT WAS 2.9 INR. AT 4:59 AM, THE RESULT WAS 3.4 INR. THE CUSTOMER WAS THEN TESTED IN A LABORATORY WITH AN UNKNOWN REAGENT AND THE RESULT WAS 2.38 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER TOOK NO ALTERNATE THINNERS, HAD NO ANTIPHOSPHOLIPID ANTIBODIES, NO TEMPORARY MEDICATION, AND NO DIET OR HEALTH FLUCTUATIONS. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR FURTHER INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 250321-12) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT COAGUCHEK XS PT TEST STRIP (LOT 124158-80). 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 AND RETENTION MATERIAL PERFORMED AS SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18798 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032112

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR