BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8023416 · Received October 31, 2018

    Report

    Report Number
    1823260-2018-03956
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 31, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702128101
    PMA / PMN Number
    K062925
    Removal / Correction Number
    1823260-08/30/18-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF DISCREPANT INR RESULTS BETWEEN A COAGUCHEK XS PRO METER OF UNKNOWN SERIAL NUMBER AND A LAB USING AN UNKNOWN REAGENT. ON (B)(6) 2018 THE CUSTOMER TESTED THE PATIENT BY FINGERSTICK AND THE RESULT WAS 5.6 INR. THE PATIENT HAD A LAB TEST WITHIN 7 HOURS AND THE RESULT WAS 3.4 INR. ON (B)(6) 2018 THE CUSTOMER TESTED THE PATIENT BY FINGERSTICK AND THE RESULT WAS 4.9 INR. THE PATIENT HAD A LAB TEST WITHIN 7 HOURS AND THE RESULT WAS 3.0 INR. THE PATIENT HAS A THERAPEUTIC RANGE OF 2.0-3.0 INR. PATIENT HAS NO ANTIPHOSPHOLIPID ANTIBODIES, NO HEPARIN OR DIRECT THROMBIN INHIBITORS, NEW MEDICATIONS, NO DIET CHANGES, NO SIGNS OR SYMPTOMS OF BLEEDING AND IS NOT ANEMIC. THE PATIENT HAS BEEN FIGHTING A COLD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. RETENTION TEST STRIPS (330463) 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866487 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 33046312 00365702128101

    Patients

    Seq Age Sex Outcome Treatment
    1