BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7203223 · Received January 18, 2018

    Report

    Report Number
    1823260-2018-00170
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 30, 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
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED STRIPS AND RETENTION METER WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR INR: 2.0 INR AND 2.4 INR. DONOR HCT: 44% AND 42%. DONOR 1: MASTER LOT / CUSTOMER STRIP AND RETENTION METER 2.0 INR/ 2.0 INR. DONOR 2: MASTER LOT / CUSTOMER STRIP AND RETENTION METER 2.4 INR/ 2.4 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MET THE SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULTS AT 1:23 PM WERE 5.4 INR AND 7.3 INR. TWO SEPARATE FINGERS WERE USED FOR THE TESTING. CUSTOMER STATED THE PATIENT'S COUMADIN DOSE WAS DECREASED BASED ON THE METER RESULT OF 5.4 INR. THE CUSTOMER BELIEVED THE RESULT OF 7.3 INR WAS INCORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT WAS NOT ANEMIC, HAD NO ANTIPHOSPHOLIPID ANTIBODIES, NO HEPARIN THERAPY, OR DIRECT THROMBIN INHIBITORS. THERE WERE NO CHANGES TO COUMADIN DOSE, NO NEW MEDICATIONS, NO DIET CHANGES, AND NO RECENT ILLNESSES. THE PATIENT HAD NO SYMPTOMS OF BLEEDING OR BRUISING. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. 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
    47981 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032112

    Patients

    Seq Age Sex Outcome Treatment
    1