BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT

    MDR report key: 5805700 · Received July 19, 2016

    Report

    Report Number
    2432235-2016-00386
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 22, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K141999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE FOUND THAT THE RING LOADER STANDARD CUVETTE FAILED TO DROP. THE CSE VERIFIED THAT THE ASPIRATE TUBE WAS SPLIT AND COULD NOT ABSORB THE LIQUID STICKING TO THE CUVETTE SENSOR. THE CSE REPLACED THE SENSOR, INSTALLED ASPIRATE PROBE TUBING AND RAN QUALITY CONTROLS. THE CAUSE OF THE DELAY IN REPORTING OF PATIENT RESULTS WAS DUE TO A MALFUNCTION OF THE ASPIRATE PROBE TUBING. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00386 WAS FILED ON JULY 19, 2016. CORRECTED INFORMATION (11/22/2016): THE INITIAL MDR STATES THAT THE DATE RECEIVED BY MANUFACTURER IS 07/06/2016. THE CORRECT DATE IS 06/22/2016. CORRECTED INFORMATION (12/01/2016): THE INITIAL MDR STATES THAT 510(K) OF THE ADVIA CENTAUR XPT INSTRUMENT IS K971418. THE CORRECT 510(K) NUMBER IS K141999. UPDATED WITH THIS INFORMATION.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR XPT INSTRUMENT CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST AND STATED THAT THERE WAS A LEAK DURING THE DAILY CLEANING PROCEDURE. THE OPERATOR DISCOVERED THAT THE ASPIRATE PROBE TUBING WAS SPLIT AND COULD NOT ASPIRATE AND THE LIQUID OVERFLOWED WITH THE CUVETTE IN THE INCUBATION RING. THE OPERATOR REPORTED THAT THERE WAS DELAY IN REPORTING OF PATIENT SAMPLES FOR APPROXIMATELY FOUR HOURS, WHICH WERE BEING TESTED AS STAT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456820 ADVIA CENTAUR XPT CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT

    Patients

    Seq Age Sex Outcome Treatment
    1