BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3243085 · Received July 23, 2013

    Report

    Report Number
    2432235-2013-00330
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER HAD AN INJURY WHILE TRYING TO CLEAR A TIP WASTE JAM IN THE LOWER TIP WASTE CHUTE. THE SUSPECT CHUTES WERE NOT BEING MAINTAINED/ CLEANED WHICH CAUSED A JAM. CSE WENT OVER MAINTENANCE AND TROUBLESHOOTING WITH CUSTOMER AND HAD CUSTOMER PERFORM MAINTENANCE AND TROUBLESHOOTING BY REMOVING CHUTES. CUSTOMER WILL PERFORM USER MAINTENANCE AND TROUBLESHOOTING. THE CAUSE OF THE TIPS FALLING ON THE OPERATOR IS DUE TO A JAM. THE CAUSE OF THE JAM IS DUE TO A USER FAILURE TO APPROPRIATELY MAINTAIN THE CHUTES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR OF AN ADVIA CENTAUR XP WAS TRYING TO CLEAR A SAMPLE PROBE HORIZONTAL MOVE ERROR. SHE REACHED INTO THE CHUTE TO CLEAR A JAM. DURING THE TROUBLESHOOTING HER LAB COAT PULLED AWAY FROM HER GLOVE AND HER WRIST WAS EXPOSED. SHE SCRAPED HER WRIST AND THEN APPROXIMATELY 80 SAMPLE TIPS FELL ON THE EXPOSED AREA. THE OPERATOR WENT TO EMPLOYEE HEALTH AND WAS GIVEN PREVENTATIVE MEDICATION. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SAMPLE TIPS FALLING ON OPERATOR'S WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343333 ADVIA CENTAUR XP CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1