BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7133389 · Received December 20, 2017

    Report

    Report Number
    1823260-2017-03077
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 12, 2017
    Report Date
    January 17, 2018
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE METER. THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. TWO HUMAN BLOOD SAMPLES FROM WARFARIN DONORS AND INTERNAL REFERENCE METERS WERE USED. DONOR #1 INR: 2.9 INR. DONOR #2 INR: 2.0 INR. DONOR #1 HCT: 53%. DONOR #2 HCT: 45%. DONOR #1: MASTER LOT: 3.0 INR. DONOR #1: CUSTOMER METER AND MASTER LOT STRIPS: 3.0 INR. DONOR #2: MASTER LOT: 2.0 INR. DONOR #2: CUSTOMER METER AND MASTER LOT STRIPS: 2.0 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED MATERIAL AND THE RETENTION MATERIAL MEET THE SPECIFICATION. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED FOR THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT RETURNED. NO INFORMATION WAS PROVIDED IN THE COMPLAINT THAT WOULD POINT TO A CAUSE FOR THE DISCREPANT RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INR RESULTS FOR 1 PATIENT TESTED ON 2 COAGUCHEK XS METERS WITH 2 DIFFERENT STRIP LOTS. THIS MEDWATCH WILL COVER STRIP LOT 24403114. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON STRIP LOT 23547511. THE PATIENT WAS TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) USING STRIP LOT 24403114 AT 2:43 P.M. AND THE RESULT WAS 4.8 INR WITH A DATA FLAG. THE PATIENT WAS TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4) USING STRIP LOT 23547511 AT 3:00 P.M. AND THE RESULT WAS 6.9 INR WITH A DATA FLAG. THE PATIENT¿S THERAPEUTIC RANGE IS 2.0 ¿ 3.0 INR. A VENOUS SAMPLE WAS DRAWN TO CHECK THE PATIENT¿S INR AT THE LABORATORY AND TO PERFORM A COMPLETE BLOOD COUNT. THESE RESULTS WERE NOT AVAILABLE. THE PATIENT¿S WARFARIN IS BEING HELD UNTIL THE LABORATORY RESULTS ARE RETURNED. NO ADVERSE EVENT OCCURRED. THE PATIENT IS IN STABLE CONDITION. BOTH METERS AND ASSOCIATED TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244031-14) 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 MATERIAL WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912603 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 24403114

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR