BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK® XS SYSTEM

    MDR report key: 1656092 · Received April 12, 2010

    Report

    Report Number
    1823260-2010-02138
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    May 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    THE MAUDE DATABASE WAS REVIEWED ON (B)(6) 2009 AND MEDWATCH REPORT NUMBER (B)(4) WAS DISCOVERED. THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED. THE COMPLAINT DATABASE WAS REVIEWED; A CUSTOMER COMPLAINT FOR THIS FAILURE WAS NOT RECEIVED BY BAXA PRIOR TO THIS REPORT. A COMPLAINT WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. MEDWATCH (B)(4) DESCRIPTION: " A CENTRAL VENOUS NUTRITION (B)(4) BAG FOR THE PT WAS HUNG ON THE IV POLE. THE MATERIAL OF THE BAG WAS DIFFERENT AND WEAKER THAN PREVIOUS BAGS USED FOR (B)(4). THE HOLE FOR HANGING THE BAG ONTO THE IV POLE TORE UNDER THE STRAIN OF THE (B)(4) OF FLUID WEIGHT. ABOUT 1/3 OF THE LIQUID IN THE BAG DRAINED OUT DUE TO THE FALL OF THE BAG AND TEAR OF THE IV TUBING."

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 4.4 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 3.2 INR. NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK® XS SYSTEM PROTHROMBIN TIME TEST STRIPS GJS ROCHE DIAGNOSTICS NA 20179531

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR