BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7809634 · Received August 23, 2018

    Report

    Report Number
    1823260-2018-02843
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 3, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702128101
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S STRIPS WERE RETURNED FOR INVESTIGATION. TESTING RESULTS: (B)(6). THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION MASTER LOT STRIP LOT - QC LOT. (1.9 - 2.9INR). ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. THE MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS WAS 0 %. THE SAME FINGER WAS USED DURING THE SECOND TEST. ACCORDING TO PRODUCT LABELING USING THE SAME FINGER CAN CAUSE RESULT DISCREPANCY. MEDWATCH FIELDS DEVICE AVAILABLE FOR EVALUATION? AND DEVICE EVALUATED BY MFR? HAVE BEEN UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE INR RESULTS FOR 2 PATIENTS FROM TWO COAGUCHEK XS METERS SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THERE WERE DISCREPANT INR RESULTS FOR 1 PATIENT. AT 09:00 AM, THE RESULT FROM THE COAGUCHEK METER (B)(4) WAS 2.4 INR. AT 09:02 AM, THE RESULT FROM THE COAGUCHEK METER (B)(4) WAS 1.9 INR. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT WAS "STABLE". THE PATIENT WAS NOT ANEMIC, NO HEPARIN, NO ANTIPHOSPHOLIPID ANTIBODIES, AND NO DIRECT THROMBIN INHIBITORS. THE PATIENT HAS HAD NO CHANGES IN DIET, NO CHANGES IN MEDICATIONS, NO BLEEDING, AND NO BRUISING. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0 INR. THE CUSTOMER SAW THE QC CHECKMARK ON BOTH METERS. THE SUSPECT PRODUCT WAS REQUESTED TO BE RETURNED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034) WERE TESTED IN COMPARISON WITH THE CURRENT MASTER LOT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649883 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403412 00365702128101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR