BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 10388461 · Received August 10, 2020

    Report

    Report Number
    1823260-2020-01945
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 5, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K170960
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REQUEST FROM FDA: THERE IS ONE INCONSISTENCY FOR 1823260-2020-01945. IN THE EVENT DESCRIPTION, IT WAS REPORTED FOR COAGUCHEK VANTUS. HOWEVER, IN SECTION D1 AND G5 (K062925) OF THE MDR REPORT, IT WAS FOR COAGUCHEK XS SYSTEM. WE NOTICED THAT ONLY THE MANUAL FOR VANTUS CONTAINS W-45 ERROR MESSAGE. PLEASE CONFIRM THE EVENT WAS ASSOCIATED WITH VANTUS. RESPONSE FROM MANUFACTURER: I CAN CONFIRM THAT THE METER USED WAS A VANTUS METER WITH COAGUCHEK XS PT STRIPS. THE COAGUCHEK XS PT STRIPS ARE USED WITH BOTH THE COAGUCHEK VANTUS AND COAGUCHEK XS METERS AND ARE CLEARED UNDER TWO DIFFERENT 510(K) NUMBERS. THE METER AND STRIPS HAVE DIFFERENT PART NUMBERS. FOR POTENTIAL ERRONEOUS RESULTS REPORTS, ON THE MDR, WE USE THE PART NUMBER FOR THE STRIPS THAT WERE USED DURING THE REPORTED EVENT AND THE ASSOCIATED 510(K) NUMBER FOR THE OVERALL SYSTEM ON THE MEDWATCH FORM. WE WILL UPDATE THE 510(K) NUMBER FOR THIS CASE TO THE VANTUS SYSTEM 510(K) NUMBER VIA A SUPPLEMENTAL REPORT. MEDWATCH FIELD G5 - PMA/510(K) # WAS UPDATED.

    Additional Manufacturer Narrative · 0

    REQUEST FROM FDA: ADDITION QUESTION: WHAT IS THE W-45 ERROR MESSAGE? WHAT CONDITION(S) CAN TRIGGER THIS ERROR MESSAGE? RESPONSE FROM MANUFACTURER: FOR THIS CASE, WE REPORTED AS A USE ERROR AS WE BELIEVE THAT THE METER PERFORMED AS INTENDED DUE TO THE FOLLOWING: ON (B)(6) 2020, THE METER PROVIDED A RESULT OF >6.0 INR (ACCORDING TO THE PATIENT) WHICH IS ABOVE THE PATIENT¿S THERAPEUTIC RANGE. THIS APPEARS TO BE A CORRECT RESULT AS THE PATIENT WAS SUBSEQUENTLY TREATED FOR HIGH INR. THE PATIENT DID NOT SEEK MEDICAL ADVICE OR INTERVENTION AT THIS POINT. THE PATIENT DID NOT TEST AGAIN UNTIL (B)(6) 2020. AT THAT TIME, A W-45 ERROR WAS RECEIVED FIVE TIMES. TO ANSWER YOUR QUESTION, THE MANUAL DEFINES A W-45 ERROR AS "UNUSUAL SAMPLE: REPEAT TEST WITH A FRESH SAMPLE AND WITH A NEW TEST STRIP. IF ERROR PERSISTS, CONTACT YOUR HEALTHCARE PROFESSIONAL WITHOUT DELAY." A W-45 ERROR DISPLAYS WITH ABNORMAL OR UNUSUALLY LONG CLOTTING TIMES. THE W-45 ERROR IN THIS CASE WAS LIKELY DISPLAYED BECAUSE THE METER COULD NOT IDENTIFY A COAGULATED SAMPLE. THIS MEANS THAT THE VALUE WAS MUCH HIGHER THAN THE MEASURING RANGE, AND NO COAGULATION WAS MEASURED IN A PREDEFINED TIME INTERVAL. THE PATIENT DID NOT CONTACT HER HEALTHCARE PROFESSIONAL UPON RECEIVING THE W-45 ERRORS. THE HOSPITAL DOCTOR CALLED THE PATIENT, ASKING HER TO RETURN TO THE ER. AT THAT POINT, THE PATIENT HAD A LAB RESULT OF 12.8 INR AND WAS TREATED WITH VITAMIN K. THE METER WAS NOT RETURNED, HOWEVER THE PATIENT DID RETURN THE TEST STRIPS. THE RETURNED STRIPS WERE TESTED ON A REFERENCE METER WITH TWO HIGH LEVEL CONTROL SAMPLES AND THE RESULTS WERE IN RANGE WITH NO ERROR MESSAGES OCCURRING. RETENTION SAMPLES WERE ALSO TESTED AND FOUND TO BE ACCEPTABLE. NO ERROR MESSAGES OCCURRED. IT CANNOT BE EXCLUDED THAT A POTENTIAL CAUSE OF THE HIGH INR WAS THE INTERACTION BETWEEN COUMADIN/ WARFARIN AND FLAGYL. THE MOST LIKELY CAUSE OF THE SUBSEQUENT VITAMIN K TREATMENT WAS THE PATIENT NOT SEEKING MEDICAL ADVICE OR INTERVENTION WHEN THE RESULT WAS >6.0 AND NOT CONTACTING HER HEALTHCARE PROFESSIONAL PER THE PRODUCT LABELING WHEN THE W-45 ERRORS WERE RECEIVED 2 DAYS LATER. IF THE PATIENT LEFT THE HOSPITAL WITHOUT UNDERSTANDING THE POTENTIAL INTERACTION BETWEEN FLAGYL AND COUMADIN/ WARFARIN THIS MAY ALSO HAVE CONTRIBUTED TO THE EVENT AS THE PATIENT DID NOT KNOW HOW TO APPROPRIATELY ADJUST DOSAGES. WITH THE INFORMATION PROVIDED AND THE INFORMATION OBTAINED THROUGH THE INVESTIGATION, WE BELIEVE THE METER PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE REPORTER'S TEST STRIPS WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED USING A RETENTION METER AND CONTROLS. TESTING RESULTS (QC RANGE = 2.5 - 3.9 INR): QC 1: 2.7 INR, QC 2: 2.7 INR, QC 3: 2.7 INR. THE OBTAINED QC VALUES WERE IN THE ALLOWED RANGE OF THE USED COMBINATION STRIP LOT - QC LOT. ALL MEASUREMENTS WERE WITHOUT ERROR MESSAGES. CUSTOMER STATED THEY HAVE APA SYNDROME. PER PRODUCT LABELING, THIS MAY CAUSE FALSE-HIGH INR VALUES AND FALSE-LOW QUICK VALUES. WHERE APA IS KNOWN TO BE PRESENT, IT IS IMPERATIVE THAT A RESULT BE OBTAINED USING AN APA-INSENSITIVE LABORATORY METHOD FOR COMPARISON. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED. OCCUPATION WAS LAY USER/PATIENT.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULTS AND ERROR MESSAGES FROM COAGUCHEK VANTUS SERIAL NUMBER (B)(4). THE CUSTOMER STATED SHE WAS IN THE HOSPITAL FOR A KIDNEY INFECTION ON (B)(6) 2020 INTO THE EARLY MORNING ON (B)(6) 2020. SHE REMOVED THE IV HERSELF AND WALKED OUT OF THE ER WITHOUT NOTIFYING ANY MEMBER OF THE MEDICAL STAFF. ON (B)(6) 2020 AT 1:30 AM, THE METER RESULT WAS >6.0 INR. ON (B)(6) 2020, THE CUSTOMER RECEIVED ERROR MESSAGE W-45 FIVE TIMES. PER PRODUCT LABELING AND THE METER DISPLAY, THIS MESSAGE INDICATES "UNUSUAL SAMPLE. REPEAT TEST WITH A FRESH SAMPLE AND WITH A NEW TEST STRIP. IF ERROR PERSISTS, CONTACT YOUR HEALTHCARE PROFESSIONAL WITHOUT DELAY." THE PATIENT IGNORED THIS VERY IMPORTANT MESSAGE GIVEN AS FAIL SAFE FROM THE METER DISPLAY. ON (B)(6), THE DOCTOR CALLED HER ASKING HER TO RETURN TO THE ER AND SHE WAS GIVEN VITAMIN K FOR A RESULT OF 12.8 INR. SHE WAS TAKING FLAGYL AND WAS INFORMED BY A DOCTOR THAT WAS THE CAUSE OF HER INR INCREASING. SHE STATED IF SHE HAD KNOWN WHAT HER INR RESULT WAS, SHE WOULD HAVE GONE TO THE ER SOONER. THE CUSTOMER STATED SHE WAS UNABLE TO OBTAIN A RESULT DUE TO RECEIVING ERRORS. NO DOSE CHANGES BASED ON METER RESULTS WERE PROVIDED. THE CUSTOMER'S THERAPEUTIC RANGE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851365 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 44009621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention