BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7955442 · Received October 11, 2018

    Report

    Report Number
    1823260-2018-03554
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 11, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    1823260-08/30/18-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS BETWEEN COAGUCHEK XS PRO METER U76011667 AND A LAB USING AN UNKNOWN REAGENT. THE CUSTOMER TESTED A PATIENT AND THE RESULT WAS 7.1 INR. PATIENT HAD A LAB TEST AND THE RESULT WAS 4.1 INR. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING THE PATIENT OR THE TEST. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT RETENTION TEST STRIPS (297788) WERE TESTED IN COMPARISON TO MASTERLOT #28632180 (RECALIBRATED LOT TO RTF/09) ON INTERNAL REFERENCE METERS. FOR THIS PURPOSE, TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION MATERIAL AS TESTED COMPLIES WITH SPECIFICATION. EXTENSIVE MEASUREMENTS HAVE SHOWN HIGHER DEVIATIONS FOR COAGUCHEK VALUES > 4.5 INR COMPARED TO A LABORATORY METHOD. THEREFORE, THE CUSTOMER ALLEGATION HAS BEEN SUBSTANTIATED. A PRODUCT PROBLEM HAS BEEN FOUND FOR COAGUCHEK VALUES > 4.5 INR, WHICH WAS THE CASE IN THIS COMPLAINT. THIS CAN BE TRACED BACK TO THE CALIBRATION OF THE COMPLAINED TEST STRIPS TO THE WHO STANDARD RTF/16. FOR MEASUREMENTS > 4.5 INR. THE CUSTOMER IS ADVISED TO CONTACT THE PHYSICIAN AND PERFORM A MEASUREMENT WITH A LABORATORY METHOD. ROCHE DIAGNOSTICS HAS ISSUED A RECALL FOR THIS ISSUE. PLEASE REFER TO MEDWATCH FIELD H9- CORRECTION/REMOVAL REPORT NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796032 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 29778813

    Patients

    Seq Age Sex Outcome Treatment
    1