BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3942510 · Received July 17, 2014

    Report

    Report Number
    2432235-2014-00445
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00445 WAS FILED ON JULY 17, 2014.MDR 2432235-2014-00445 SUPPLEMENTAL 1 WAS FILED ON AUGUST 15, 2014.ADDITIONAL INFORMATION (08/26/2014): A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST DETERMINED THAT THE CAUSE OF DISCORDANT TROPONIN RESULTS IS CONTAMINATION. THE CUSTOMER MUST ADDRESS THE WATER CONTAMINATION ISSUE BEFORE A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) CAN BE DISPATCHED TO DECONTAMINATE THE INSTRUMENT. SIEMENS IS STILL INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00445 WAS FILED ON JULY 17, 2014. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE RAN NUMEROUS PRECISION TESTING, ALL RESULTING WITHIN RANGE. THE CSE PREVENTIVELY REPLACED THE WASH BLOCKS AND RAN ADDITIONAL PRECISION TESTING, ALL RESULTING WITHIN RANGE. CALIBRATIONS AND QUALITY CONTROLS WERE RUN, ALSO RESULTING WITHIN RANGE. WATER QUALITY CHECKS WERE PERFORMED ON AUGUST 11, 2014, WHICH REVEALED THE PRESENCE OF BACTERIAL CONTAMINATION ON THE SYSTEM. SIEMENS IS STILL INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00445 WAS FILED ON JULY 17, 2014. MDR 2432235-2014-00445 SUPPLEMENTAL 1 WAS FILED ON AUGUST 15, 2014. MDR 2432235-2014-00445 SUPPLEMENTAL 2 WAS FILED ON SEPTEMBER 19, 2014. ADDITIONAL INFORMATION (09/29/2014): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE AND DECONTAMINATED THE INSTRUMENT. NO FURTHER ISSUES WERE OBSERVED FOLLOWING THE INSTRUMENT DECONTAMINATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE REPLICATE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED MULTIPLE TIMES ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418022 ADVIA CENTAUR XP CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1