BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 8784580 · Received July 12, 2019

    Report

    Report Number
    1823260-2019-02548
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 20, 2019
    Report Date
    July 12, 2019
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S TEST STRIPS AND METER WERE REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. THEREFORE, THE COMPARABILITY TO OTHER HUMAN RECOMBINANT THROMBOPLASTINS IS BEST, WHEREAS HIGHER DEVIATIONS CAN OCCUR WITH OTHER THROMBOPLASTINS. HOWEVER, THOSE HIGHER DIFFERENCES BETWEEN THROMBOPLASTINS OF DIFFERENT (RABBIT, BOVINE BASED) ORIGIN ARE NOT A COAGUCHEK SPECIFIC ISSUE. SIMILAR DIFFERENCES CAN BE OBSERVED WHEN A HUMAN RECOMBINANT THROMBOPLASTIN-BASED LABORATORY METHOD IS COMPARED AGAINST SEVERAL OTHER (RABBIT, BOVINE-BASED) LABORATORY METHODS. RELEVANT RETENTION TEST STRIPS (LOT 381237) WERE TESTED IN COMPARISON WITH THE MASTER LOT COAGUCHEK XS PT. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. RETENTION SAMPLES WERE ACCEPTABLE. NO ERROR MESSAGES OCCURRED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE HIGH INR RESULTS FROM A COAGUCHEK XS METER SERIAL NUMBER (B)(4) COMPARED TO THE STAGO NEOPLASTIN LABORATORY METHOD. AT 11:30 AM THE METER RESULT WAS 5.9 INR. AT 12:30 PM THE METER RESULT WAS 5.7 INR. AT 1:30 THE LABORATORY RESULT WAS 3.7 INR. THE LABORATORY RESULT WAS DEEMED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THEY ARE FEELING FINE. THE CUSTOMER'S THERAPEUTIC RANGE IS 3.5 - 4.0 INR. THE CUSTOMER DOES TAKE ASPIRIN. IN MAY THE CUSTOMER WAS TAKING ANTIBIOTICS AS A TOE WAS REMOVED DUE TO AN INFECTION. THE CUSTOMER NOW HAS ANOTHER TOE THAT IS INFECTED AND WILL BE STARTING ANOTHER ROUND OF ANTIBIOTICS. THE CUSTOMER STATED THAT THEIR APPETITE IS LOW DUE TO A STROKE THEY HAD IN (B)(6) 2019. THE STROKE WAS UNRELATED TO THE USE OF THE METER. THE CUSTOMER IS ON MEDICAL MARIJUANA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578145 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 38123722

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ASPIRIN| LANTIS| LIPITOR| LISINOPRIL| MEDICAL MARIJUANA| METOPROLOL| WARFARIN