BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7130658 · Received December 19, 2017

    Report

    Report Number
    1823260-2017-03025
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 7, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A ROUTINE RETENTION TESTING PROCESS HAS BEEN IMPLEMENTED DURING WHICH ALL TEST STRIPS THAT HAVE BEEN RELEASED ARE TESTED EVERY THREE MONTH IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. IF A FAILING RESULT IS OBSERVED DURING TESTING, APPROPRIATE ACTIONS WILL BE TAKEN. THE OBTAINED RESULTS SHOWED A MAXIMUM DIFFERENCE OF 0.2 INR BETWEEN RETENTION SAMPLES AND MASTERLOT FOR INR VALUES = 2.0 INR, AND 10% FOR INR VALUES = 2.0 INR. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE INCONSPICUOUS AND RETENTION MATERIAL COMPLIES WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    ONE VIAL OF TEST STRIP LOT 244039-17 CONTAINING >10 TEST STRIPS AND THE COAGUCHEK METER WERE RECEIVED FOR INVESTIGATION. THE TEST STRIPS AND VIAL SHOWED NO DEFECTS. THE METER APPEARED UNDAMAGED AND WAS CLEAN ON THE OUTSIDE. THE RETURNED TEST STRIPS WERE MEASURED WITH THE RETURNED METER 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 INTERNAL REFERENCE METERS WERE USED. MASTER LOT/RETENTION METER: MARCUMAR 3: 1.8 INR; MARCUMAR 4: 2.0 INR . CUSTOMER STRIPS/CUSTOMER METER: MARCUMAR 3: 1.9 INR; MARCUMAR 4: 1.9 INR. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WITH THE SAME BLOOD SAMPLE WAS 5 %. THE RETURNED CUSTOMER MATERIAL AND RETENTION MATERIAL COMPLIED WITH SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FROM COAGUCHEK INRANGE METER (B)(4). THE COAGUCHEK INRANGE METER IS NOT SOLD IN AND IS NOT LIKE OR SIMILAR TO A PRODUCT SOLD IN THE UNITED STATES. THE RESULTS FROM THE METER WERE 4.4 INR AND 4.6 INR. THE VENOUS SAMPLE DRAWN WITHIN 30 MINUTES WAS TESTED IN A LABORATORY USING DADE INNOVIN REAGENT AND THE RESULT WAS 3.5 INR. THE CUSTOMER WAS AT THE HOSPITAL RECEIVING TRAINING ON THE METER WHEN THE DISCREPANCY OCCURRED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE THERAPEUTIC RANGE WAS 2.5 TO 3.5 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910991 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 244039-17

    Patients

    Seq Age Sex Outcome Treatment
    1