BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7041212 · Received November 17, 2017

    Report

    Report Number
    1823260-2017-02648
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 17, 2017
    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

    THE RETURNED METER AND MASTERLOT STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTERLOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR INR: 2.7 INR AND 2.2 INR. DONOR HCT: 48.5% AND 45%. DONOR #1: MASTER LOT / CUSTOMER STRIP AND CUSTOMER METER 2.7 INR/ 2.7 INR. DONOR #2: MASTER LOT / CUSTOMER STRIP AND CUSTOMER METER 2.2 INR/ 2.1 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. RELEVANT RETENTION TEST STRIPS (LOT 223855-23) 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. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN ERROR MESSAGE INDICATING AN ISSUE APPLYING BLOOD TO THE TEST STRIP AND RECEIVED A QUESTIONABLE LOW RESULT FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT AT 11:53 AM WAS 2.2 INR AND THE RESULT AT 2 PM FROM A DOCTOR'S COAGUCHEK XS METER WAS 3.2 INR. THERE WAS NO TREATMENT RECEIVED AND NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS NOT ANEMIC, NOT ON HEPARIN, HAD NO ANTIPHOSPHOLIPID ANTIBODIES, NO CHANGE IN COUMADIN, NO NEW MEDICATION, NO CHANGE IN DIET, AND NO ILLNESS. THE THERAPEUTIC RANGE WAS 2.5-3.5 INR. THE CUSTOMER DID NOT HAVE THE VIAL OF STRIPS USED AND COULD NOT RETURN THEM FOR INVESTIGATION. THE METER WAS REQUESTED TO BE RETURNED. REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820949 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385523

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR