BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8175291 · Received December 18, 2018

    Report

    Report Number
    1823260-2018-04958
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 4, 2018
    Report Date
    December 18, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    RES Z-0360-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION IS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH INR RESULT ON COAGUCHEK XS METER WITH SERIAL NUMBER (B)(4) COMPARED TO AN UNSPECIFIED LABORATORY METHOD. THE RESULT FROM THE METER AT 1:30 P.M. WAS > 8.0 INR. THE RESULT FROM THE LABORATORY AT 3:30 P.M. WAS 5.4 INR. THE LABORATORY RESULT WAS BELIEVED TO BE CORRECT. THE DOCTOR HELD THE CUSTOMER'S COUMADIN BASED ON THE RESULT OF 5.4 INR. THE CUSTOMERS' THERAPEUTIC RANGE IS 2.0 - 3.0 INR. NO ADVERSE EVENT OCCURRED DUE TO THE DEVICE. THE CUSTOMER FEELS FINE. THE CUSTOMER HAD RECENTLY BEEN RELEASED FROM THE HOSPITAL. THE CUSTOMER HAD A BROKEN ARM (UNRELATED TO THE USE OF THE DEVICE) AND THE MEDICINE THEY GAVE HER "TOOK THE SALT OUT OF HER BODY" CAUSING A TIA. THE CUSTOMER WAS RECENTLY ON LASIX AND POTASSIUM BUT HER DOCTOR HAS SINCE STOPPED THESE MEDICATIONS. THE CUSTOMER IS ANEMIC. THE CUSTOMER IS NOT TAKING HEPARIN OR OTHER DIRECT THROMBIN INHIBITORS. THE CUSTOMER DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE CUSTOMER WAS ADVISED TO EAT MORE SALAD (VITAMIN K) BY HER DOCTOR BASED ON THE 5.4 INR RESULT. THE CUSTOMER HAS RECENTLY HAD SOME RE-FLUX SINCE (B)(6) 2018. THE CUSTOMER HAS NOT HAD ANY UNUSUAL BLEEDING OR BRUISING. THE COMPLAINED TEST STRIPS HAVE BEEN CALIBRATED AGAINST THE WHO STANDARD AND ARE IN SCOPE OF THE ROCHE INITIATED RECALL. FOR THESE TEST STRIPS THERE IS A POTENTIAL FOR A PRODUCT PROBLEM WHEN THE INR IS > 4.5. VALUES > 4.5 INR SHOWED AN INCREASING POSITIVE BIAS. THE INFORMATION IN THE CASE IS CONSISTENT WITH THE DETAILS OF THE RECALL AND THE ISSUE HAS BEEN FULLY INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015436 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 29415123

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR