BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 7333422 · Received March 13, 2018

    Report

    Report Number
    1823260-2018-00783
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 22, 2018
    Report Date
    March 13, 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 · 1

    (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED THAT THEY RECEIVED A QUESTIONABLE HIGH INR RESULT ON A COAGUCHEK XS METER WITH SERIAL (B)(4). (B)(6). DIFFERENT FINGERS WERE USED FOR EACH METER TEST. THE CUSTOMER CONSIDERS BOTH THE 2.8 INR AND 2.4 INR RESULTS TO BE CORRECT. THE CUSTOMER DID NOT REPORT THESE RESULTS TO HER DOCTOR. THE CUSTOMER'S THERAPEUTIC RANGE IS 2.0 - 3.0 INR. THE CUSTOMER STATED THAT THE METER HAD NOT BEEN CLEANED BEFORE. THE CUSTOMER NOTICED A FEW GRAY SMUDGES ON THE METER'S STRIP GUIDE. THE CUSTOMER WASHED THEIR HANDS BEFORE PERFORMING THE FINGERSTICK AND WERE ALLOWED TO DRY. THE BLOOD SAMPLE WAS APPLIED TO THE STRIP WITHIN 15 SECONDS. THE CUSTOMER HAS NO HEMATOCRIT CONCERNS, NO ANTIPHOSPHOLIPID ANTIBODIES, ON NO NEW MEDICATIONS, AND NO ADDITIONAL ILLNESSES. THE CUSTOMER HAD EATEN RED CABBAGE PRIOR TO TESTING. THE CUSTOMER DID STATE THAT HER WARFARIN DOSE HAD BEEN DECREASED, BUT IT WAS LATER STATED THAT THE METER RESULTS DID NOT LEAD TO A CHANGE IN DOSAGE. THE CUSTOMER'S CURRENT CONDITION IS SHE FEELS FINE. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION. REPLACEMENT PRODUCT WAS SENT. 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. (B)(6). ALL INR VALUES WERE WITHIN THE SPECIFIED MAXIMUM DIFFERENCE BETWEEN MEASUREMENTS. NO ERROR MESSAGES OCCURRED. THE RETURNED AND THE RETENTION MATERIAL MEET SPECIFICATIONS. THE INVESTIGATION NOTED THAT SINCE THE CUSTOMER HAD ADMITTED TO EATING RED CABBAGE PRIOR TO TESTING, WHICH CONTAINS VITAMIN K, THE INR VALUES COULD POSSIBLY BE AFFECTED. 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. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177241 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 25032221

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR