BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1854326 · Received October 5, 2010

    Report

    Report Number
    1823260-2010-05899
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM AND 4.07 INR ON A COMPARISON LAB. CALLER STATES THAT THE COUMADIN HAD PREVIOUSLY BEEN HELD FOR ONE DAY. CALLER STATES THAT THE COUMADIN WAS HELD FOR ANOTHER DAY BASED ON THE LAB RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AN ADDITIONAL EVAR PROCEDURE ON (B)(6) 2010. THE PATIENT HAD RECEIVED A ZENITH MAIN BODY WITH ILIAC LIMBS AND OVER TIME ONE OF THE LIMBS SEPARATED CAUSING A TYPE I ENDOLEAK. THE SEPARATION OCCURRED ON THE RIGHT AT THE GRAFT TO LIMB OVERLAP. THE AREA REPRESENTATIVE STATED THAT IT APPEARED THAT THE TORTUOSITY CAUSED THE GRAFT TO PULL BACK LEADING TO THE SEPARATION. TWO ZENITH ILIAC LEG GRAFTS WERE PLACED BEFORE THE INTERNAL ILIAC TO FORM THE LIMB AND SEAL OFF THE ENDOLEAK. THE SECONDARY PROCEDURE SUCCESSFULLY SEALED THE "GAP" AND THE ENDOLEAK WAS NO LONGER PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20180032

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR COUMADIN (DAILY)| "PERMA-CATH"| NORVASC| LEVEMIR (NIGHTLY)| STOOL SOFTENER (TWICE DAILY)| PROTONIX (DAILY)| MS CONTIN (DAILY)| HYDROCODONE (AS NEEDED)| ALPRAZOLAM (3 TIMES DAILY)