BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1813265 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05047
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 2.7 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 1.8 INR. PATIENT'S COUMADIN DOSE WAS DECREASED FOR ONE DAY BASED ON METER RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    FOUR UNITS OF 250 ML MEDIBAGS WERE FOUND TO BE LEAKING WHERE THE BUSHING MEETS THE INNER OF THE BAG. THE BAGS WERE NOT USED ON PTS. THE LEAKS WERE NOTICED AT MEDICATION FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20180332

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR LOVENOX| COUMADIN| MUTIVITAMIN| FLEXERIL| FOLIC ACID| ARTIFICIAL KNEE