BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7320009 · Received March 7, 2018

    Report

    Report Number
    1823260-2018-00671
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 7, 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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND COMPLAINED OF ERRONEOUS INR RESULTS WHEN THE CUSTOMER COMPARED HER NEW COAGUCHEK XS METER SERIAL NUMBER (B)(4) AND HER OLD COAGUCHEK XS METER SERIAL NUMBER (B)(4) TO A LABORATORY USING THE DADE INNOVIN METHOD. THE CUSTOMER TESTED ON METER (B)(4) AT 9:00 A.M. WITH A RESULT OF 4.3 INR. THE RESULT FROM THE LABORATORY AT 10:30 A.M. WAS 3.1 INR. THE CUSTOMER TESTED ON METER (B)(4) AGAIN AT 5:00 P.M. AND THE RESULT WAS 4.4 INR. THE CUSTOMER ALSO TESTED ON METER (B)(4) AT 5:10 P.M. AND THE RESULT WAS 4.3 INR. THE SAME TEST STRIPS WERE USED ON BOTH METERS. THE CUSTOMER'S THERAPEUTIC RANGE IS 3.0 ¿ 3.5 INR. NO TREATMENT WAS RECEIVED. NO ADVERSE EVENT OCCURRED. THE CUSTOMER IS IN STABLE CONDITION. THE CUSTOMER IS NOT ANEMIC, HAS NO ANTIPHOSPHOLIPID ANTIBODIES AND IS NOT ON HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THERE HAVE BEEN NO CHANGES TO THE CUSTOMER'S WARFARIN DOSE, NO NEW MEDICATIONS AND NO RECENT ILLNESSES. THE CUSTOMER HAS NO SYMPTOMS OF BLEEDING OR BRUISING. BOTH METERS AND THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 250322-21) 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 MATERIAL WAS ACCEPTABLE. BOTH RETURNED METERS AND THE TEST STRIPS WERE TESTED IN COMPARISON TO A RETENTION METER AND MASTER LOT STRIPS. DONOR 1 INR: 2.4 INR, DONOR 2 INR: 2.9 INR . DONOR 1 HCT: 45%, DONOR 2 HCT: 38%. FOR METER (B)(4): DONOR 1: RETENTION METER WITH MASTER LOT STRIPS: 2.4 INR. DONOR 1: CUSTOMER METER WITH CUSTOMER STRIPS: 2.4 INR. DONOR 2: RETENTION METER WITH MASTER LOT STRIPS: 2.9 INR. DONOR 2: CUSTOMER METER WITH CUSTOMER STRIPS: 2.7 INR. FOR METER (B)(4): DONOR 1: RETENTION METER WITH MASTER LOT STRIPS: 2.4 INR. DONOR 1: CUSTOMER METER WITH MASTER LOT STRIPS: 2.4 INR. DONOR 2: RETENTION METER WITH MASTER LOT STRIPS: 2.9 INR. DONOR 2: CUSTOMER METER WITH MASTER LOT STRIPS: 2.9 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 SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163983 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR