BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1901225 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06788
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER TESTED 1.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 2.67 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT HER CUSTOMER'S TUBE HAD A LEAK AND WOULD NO LONGER HOLD AIR. THIS OCCURRED AFTER ABOUT 15 DAYS OF USE AND DID REQUIRE RECANNULATION. THE CALLER DID NOT KNOW WHAT THE SOURCE OF THE LEAK MAY HAVE BEEN; IT COULD HAVE BEEN THE CUFF OR THE PILOT LINE. THE CALLER STATED THAT THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS 20180432

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR COUMADIN| AZATHIOPRINE| "AORTIC VALVE"| RAMIPRIL| BISOPROLOL