BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7330644 · Received March 12, 2018

    Report

    Report Number
    1823260-2018-00770
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 21, 2018
    Report Date
    March 27, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED METER AND 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: 2.2 INR, DONOR 2 INR: 2.5 INR. DONOR 1 HCT: 48%, DONOR 2 HCT: 48%. TESTING RESULTS: DONOR 1: RETENTION METER WITH MASTERLOT STRIPS: 2.2 INR, CUSTOMER METER WITH CUSTOMER STRIPS: 2.1 INR. DONOR 2: RETENTION METER WITH MASTERLOT STRIPS: 2.5 INR, CUSTOMER METER WITH CUSTOMER STRIPS: 2.7 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. BLOOD FOR BOTH METER TESTS CAME FROM THE SAME FINGER STICK. THE PACKAGE INSERT STATES NEVER ADD MORE BLOOD TO THE TEST STRIP AFTER THE TEST HAS BEGUN OR PERFORM ANOTHER TEST WITH BLOOD FROM THE SAME PUNCTURE SITE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT'S WIFE STATED THAT THE PATIENT HAD BEEN GETTING ERRORS WHEN TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). THE PATIENT WENT TO THE DOCTOR'S OFFICE FOR TESTING SINCE THEY HAD TROUBLE TESTING WITH THE METER. THE PATIENT USED THE METER FOR TESTING WHILE AT THE DOCTOR'S OFFICE AND RECEIVED AN ERRONEOUS RESULT. A SAMPLE WAS COLLECTED FROM THE PATIENT WITH A CAPILLARY TUBE AND TESTED AT THE DOCTOR'S OFFICE AT APPROXIMATELY 2:30 P.M. USING AN UNKNOWN ROCHE METER BELONGING TO THE DOCTOR'S OFFICE. THE RESULT FROM THE DOCTOR'S METER WAS 2.8 INR. THE NURSE THEN WIPED BLOOD AWAY FROM THE PATIENT'S FINGER, PUSHED MORE BLOOD OUT FROM THE PATIENT'S FINGER, AND COLLECTED ANOTHER SAMPLE WITH A CAPILLARY TUBE. THIS SAMPLE WAS TESTED ON THE PATIENT'S METER, RESULTING AS 4.5 INR. ACCORDING TO THE METER MEMORY, THIS VALUE WAS MEASURED AT 2:11 P.M. THE TIME ELAPSED BETWEEN THE PATIENT'S FINGERSTICK AND APPLICATION TO THE TEST STRIP WAS GREATER THAN 15 SECONDS. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT WAS NOT TREATED BASED ON THE METER RESULTS. THE PATIENT'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE PATIENT'S TESTING FREQUENCY IS EVERY TWO WEEKS. THE PATIENT IS NOT ANEMIC AND DOES NOT HAVE ANTIPHOSPHOLIPID ANTIBODIES. THE PATIENT DOES NOT TAKE HEPARIN OR DIRECT THROMBIN INHIBITORS. THE PATIENT'S COUMADIN DOSAGE IS ALWAYS CHANGING. THE PATIENT HAD AN INR VALUE OF 3.6 INR TWO WEEKS PRIOR TO (B)(6) 2018 AND DOSAGE WAS DECREASED TO 2.5 MG THREE DAYS PER WEEK AND 1.5 MG ON OTHER DAYS. THE PATIENT HAS HAD NO NEW MEDICATIONS, NO DIET CHANGES, AN NO ILLNESSES. THE PATIENT DID NOT HAVE SYMPTOMS OF BLEEDING OR BRUISING. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. 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 SAMPLES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172964 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR DEPAKOTE| DONEPEZIL| LAMOTRIGINE| MEMANTINE| METOPROLOL| WARFARIN/COUMADIN| ZOLPIDEM