BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 6954039 · Received October 17, 2017

    Report

    Report Number
    1823260-2017-02337
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 22, 2017
    Report Date
    November 2, 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

    IT HAS BEEN CONFIRMED THAT ALL PATIENT TEST RESULTS WERE IN INR UNITS.

    Additional Manufacturer Narrative · 1

    RELEVANT RETENTION TEST STRIPS (LOT 223855) 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 WITHIN SPECIFICATIONS. THE PATIENT'S METER, SERIAL NUMBER (B)(4), WAS RETURNED FOR INVESTIGATION. THE RETURNED METER AND MASTER LOT STRIPS WERE 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: 2.7 INR, DONOR 2 INR: 2.5 INR. DONOR 1 HCT: 49%, DONOR 2 HCT: 47%. TESTING RESULTS: DONOR #1: MASTER LOT: 2.6 INR, MASTER LOT STRIP AND CUSTOMER METER: 2.7 INR. DONOR #2: MASTER LOT: 2.4 INR, MASTER LOT STRIP AND CUSTOMER METER: 2.5 INR. ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. THE PATIENT SAMPLES WERE ALWAYS IDENTIFIED AS BLOOD. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET THE SPECIFICATION. NO INFORMATION WAS PROVIDED THAT WOULD POINT TO A CAUSE FOR THE RESULT DISCREPANCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CALLED AND STATED THAT THE PATIENT RECEIVED ERRONEOUS RESULTS WHEN TESTING WITH A COAGUCHEK XS METER. THE SERIAL NUMBER OF THE METER WAS ASKED FOR, BUT NOT PROVIDED. THE PATIENT'S MOTHER COULD NOT CONFIRM IF THE UNITS OF MEASURE USED ON THE METER WERE INR UNITS. THE PATIENT TESTED ON THE METER THREE TIMES IN A ROW AT 9:35 P.M. AND EACH TIME RESULTED WITH A VALUE OF 4.0. THE RESULTS WERE DISPLAYED WITH AN ARROW IN FRONT. THE PATIENT CHANGED THE BATTERIES, RESET THE METER, AND TESTED AGAIN, RECEIVING A RESULT OF 4.0 WITH AN ARROW DISPLAYED NEXT TO IT. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE 4 SAMPLES WERE COLLECTED FOR LABORATORY TESTING. BLOOD FROM ONE OF THE VIALS WAS TESTED WITH THE PATIENT'S METER AND THE RESULT WAS 2.4 AT 10:10 P.M. A SAMPLE RESULTED AS 2.15 INR AT 10:45 P.M. WHEN TESTED WITH THE LABORATORY METHOD. IT WAS ASKED, BUT THE LABORATORY METHOD USED IS UNKNOWN. AFTER COLLECTING A SAMPLE FOR LABORATORY TESTING IN THE EMERGENCY ROOM, THE PATIENT WAS SENT HOME. NO TREATMENT WAS PROVIDED TO THE PATIENT AND SHE FOLLOWED UP WITH HER REGULAR DOCTOR. THE PATIENT WAS NOT TREATED BASED ON THE RESULTS FROM THE METER. NO ADVERSE EVENTS WERE ALLEGED. THE PATIENT'S THERAPEUTIC RANGE IS 2.5 - 3.5 INR. THE PATIENT'S TESTING FREQUENCY IS WEEKLY TO EVERY TWO WEEKS. THE PATIENT'S MOTHER COLD NOT CONFIRM IF THE PATIENT WAS ANEMIC OR NOT. THE PATIENT DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT DOES NOT TAKE HEPARIN OR DIRECT THROMBIN INHIBITORS. THE PATIENT HAS HAD NO CHANGE IN WARFARIN DOSAGE. THE PATIENT HAS HAD NO NEW MEDICATIONS, NO DIET CHANGES, AND NO ILLNESSES. THE PATIENT HAS NO SYMPTOMS OF BLEEDING OR BRUISING. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735459 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 223855

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR