BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 7555180 · Received May 30, 2018

    Report

    Report Number
    2432235-2018-00228
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    April 24, 2018
    Report Date
    July 5, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON 30-MAY-2018. ADDITIONAL INFORMATION (15-JUNE-2018): HEADQUARTER SUPPORT CENTER (HSC) HAS REVIEWED THE SERVICE REPORT AND IDENTIFIED THE CSE PERFORMED A TOTAL SERVICE VISIT (TSV). IN ADDITION TO THE TSV, A CALIBRATION OF THE SAMPLE PROBE AND REAGENT PROBES (RP2 AND RP3) WAS PERFORMED. THE BACKGROUND TEST AND RESULTS WERE IN THE ACCEPTABLE RANGE. THE CLEANING SOLUTION VALVES (V66 AND V67) WERE REPLACED, AND THE ACID AND BASE (FLUIDIC LINES) DECONTAMINATED PROACTIVELY. QUALITY CONTROLS AND MASTER CURVE MATERIAL (MCM) WERE RUN, AND THE RESULTS WERE ACCEPTABLE. THE CSE DID NOT FIND ISSUES WITH THE INSTRUMENT. HSC HAS ALSO REVIEWED A COMPARISON STUDY PERFORMED BY SIEMENS WITH LOT 241, 243, AND 245 AND DTT/RELEASING AGENT LOT 01370129D AND IDENTIFIED AN ACCEPTABLE CONTROL RECOVERY AND LOW BIAS WITH THE TEST PANEL. THE STUDY DID NOT REPRODUCE THE CUSTOMER PATIENT BIAS AND INFORMED THAT THERE IS NO PERFORMANCE ISSUE WITH THE VB12 ASSAY. ADDITIONALLY, SIEMENS PERFORMED A TITER STUDY WITH THE PREPARATION OF DTT/RELEASING AGENT TO OBSERVE THE EFFECT OF INCORRECT PREPARATION. THE RESULTS FROM THE STUDY INDICATE THAT DECREASING THE DTT/RELEASING AGENT CONCENTRATION RESULTED IN DECREASED CONTROL AND PATIENT VALUE(S) AND INCREASING DTT/RELEASING AGENT CONCENTRATION RESULTED IN INCREASED CONTROL AND PATIENT VALUE(S). BASED ON THE STUDY PERFORMED, THE POSSIBLE CAUSE OF DISCREPANT RESULTS IS DUE TO AN INCORRECT PREPARATION OF DTT/RELEASING AGENT. THE CUSTOMER HAS BEEN MADE AWARE OF THE IMPORTANCE OF FOLLOWING THE INSTRUCTION FOR USE (IFU) FOR PREPARING DTT/RELEASING AGENT. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED. SECTION H6 (RESULT CODE AND CONCLUSION CODE) WERE UPDATED. MDR # 2432235-2018-00229_S1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER INFORMED SIEMENS THAT VITAMIN B12 (VB12) LOT 241, DTT/RELEASING AGENT, WAS PREPARED INCORRECTLY AND USED FOR TESTING ON (B)(6) 2018. THE CUSTOMER ALSO INFORMED SIEMENS THAT THE INSTRUMENT HAD PREVIOUS HARDWARE ISSUES THAT WERE INVESTIGATED AND RESOLVED BY A SIEMENS CUSTOMER SERVICE ENGINEER. THE CUSTOMER HAS RUN VB12 MASTER CURVE MATERIALS (MCM) TO VERIFY THE PERFORMANCE OF THE ASSAY AND INFORMS THAT ALL LEVELS WERE WITHIN RANGE.SIEMENS IS INVESTIGATING THE ISSUE. AN ADDITIONAL MDR # 2432235-2018-00229 WAS FILED FOR DISCORDANT FALSELY ELEVATED VITAMIN B12 RESULTS OBTAINED ON (B)(6) 2018.

    Description of Event or Problem · 1

    A DISCORDANT FALSELY ELEVATED VITAMIN B12 RESULT WAS OBTAINED ON THE CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED A NEW LOT OF VITAMIN B12 ALONG WITH THE SAME PATIENT SAMPLE AND PERFORMED REPEAT TESTING ON AN ALTERNATE INSTRUMENT. THE REPEATED RESULT WAS LOWER AND A CORRECT REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE VITAMIN B12 DISCORDANT PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396065 ADVIA CENTAUR XP CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1