BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 4012544 · Received August 15, 2014

    Report

    Report Number
    2432235-2014-00472
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    December 17, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED INITIAL MDR 2432235-2014-00472 ON 15-AUG-2014 AND A FOLLOW UP/SUPPLEMENTAL REPORT WITH MFR REPORT # 2432253-2014-00472 ON 10-OCT-2014. CORRECTION (12-DEC-2019): THE MFR REPORT # FOR THE FOLLOW UP/SUPPLEMENTAL REPORT SHOULD HAVE BEEN 2432235-2014-00472. THE MFR REPORT # WAS UPDATED TO REFLECT THIS INFORMATION. THE INFORMATION DOCUMENTED IN THE FOLLOW UP/SUPPLEMENTAL REPORT SUBMITTED ON 10-OCT-2014 CAN BE FOUND BELOW: SIEMENS FILED THE INITIAL MDR 2432253-2014-00472 ON AUGUST 15, 2014. ADDITIONAL INFORMATION (09/17/2014): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA AND TROUBLESHOOTING TROPONIN IMPRECISION, THE CSE REPLACED THE ANCILLARY PROBE, ANCILLARY PLUNGER, ASPIRATE PROBE 1 PINCH VALVE, ASPIRATE PROBE 2 PINCH VALVE, INDEX MECHANISM, SERVO MOTOR, SERVO PROCESSING COMPUTER BOARD LOW LEVEL CONTROLLER, IONIZER AND THE INCUBATION RING. THE CSE CLEANED THE PINCH VALVE 2 POWER CONNECTOR DUE A BUILDUP OF CORROSION AND PERFORMED SYSTEM DECONTAMINATION. THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNKNOWN. THE INSTRUMENT IS OPERATIONAL AND PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE AND IS CURRENTLY INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TROPONIN ULTRA (TNI UL) RESULTS WERE OBTAINED ON SAMPLES FOR TWO PATIENTS RUN ON AN ADVIA CENTAUR XP INSTRUMENT. THE ELEVATED RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE INITIAL RESULTS AND THE REPEAT RESULTS FROM THE SAME INSTRUMENT, AND THE REPEAT RESULTS ON AN ALTERNATE ADVIA CENTAUR INSTRUMENT, ALL OF WHICH WERE LOWER. THE LOWER RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TNI ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491527 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1