BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6987173 · Received October 30, 2017

    Report

    Report Number
    1823260-2017-02456
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 30, 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

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FROM COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE RESULT AT 7:15 AM WAS 5.8 INR AND THE RESULT AT 7:18 AM WAS 2.8 INR. THERE WAS NO ADVERSE EVENT. THE CUSTOMER WAS NOT ANEMIC, HAD NO HEPARIN THERAPY, HAD NO CHANGES IN DOSAGE, NO NEW MEDICATION, NO DIET CHANGES, NO ADDITIONAL ILLNESS, AND NO BLEEDING OR BRUISING. THE THERAPEUTIC RANGE WAS 2.0 INR-3.0 INR. THE SUSPECT METER AND STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. THE RETURNED METER AND TWO VIALS OF TEST 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 2.5 INR, DONOR HCT: 49% AND 47%. TESTING RESULTS: VIAL#(B)(4) DONOR #1: MASTER LOT / CUSTOMER STRIP AND METER 2.6 INR/ 2.6 INR. DONOR #2: MASTER LOT / CUSTOMER STRIP AND METER 2.4 INR/ 2.4 INR. TESTING RESULTS: VIAL#(B)(4) DONOR #1: MASTER LOT / CUSTOMER STRIP AND METER 2.6 INR/ 2.6 INR. DONOR #2: MASTER LOT / CUSTOMER STRIP AND METER 2.4 INR/ 2.5 INR. ALL RESULTS 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 AND RETENTION MATERIAL PERFORMED AS SPECIFIED. NO INFORMATION WAS PROVIDED IN THE COMPLAINT CASE THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766515 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 22385523

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR