BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 5827923 · Received July 27, 2016

    Report

    Report Number
    2432235-2016-00417
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 21, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00417 WAS FILED ON JULY 27TH, 2016. ADDITIONAL INFORMATION (07/11/2016): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. SERVICE WAS PERFORMED OVER MULTIPLE VISITS. AFTER EVALUATION OF THE INSTRUMENT, THE CSE CLEANED THE REACTION TRAY WASH UNIT (WUD) AND DILUTION TRAY WASH UNIT (DWUD), CHECKED ALL MIXERS AND PROBES, CHANGED THE SAMPLE DILUTION PROBE (DPP), CHECKED THE LIMIT POINTS OF ALL PROBES, ADJUSTED THE PRESSURE OF WATER SUPPLY PUMP (LWP), AND CHECKED THE LEVEL OF THE REACTION TRAY (RRV), LAMP ENERGY AND CELL BLANK. THE CSE RAN QUALITY CONTROL (QC), RESULTING WITHIN THE EXPECTED RANGE. THE CSE RETURNED TO THE CUSTOMER SITE AND CHECKED THE PROBES AND MIXERS ALIGNMENT. THE CSE CHANGED THE SILICONE TUBES FROM MIXERS MOTORS AND REAGENT PROBE 2 SYRINGE. QC WAS RUN, RESULTING WITHIN RANGE. THE CSE RETURNED TO THE CUSTOMER SITE TO INSTALL PARTS ORDERED AT A PREVIOUS VISIT. THE CSE REPLACED ALL SEALS FOR VERTICAL PUMPS. THE CSE REVISITED THE CUSTOMER SITE. THE CSE DECONTAMINATED THE SALINE LINE AND REPLACED THE DILUTION TURN TABLE CUVETTES. THE CSE CHECKED DILUTION MIX AND DWUD NOZZLE CALIBRATION. THE CUSTOMER REPLACED THE RRV. THE SYSTEM PERFORMANCE WAS MONITORED, AND NO OTHER ISSUES WERE NOTED. THE CAUSE OF THE DISCORDANT, FALSELY LOW GLUCOSE HEXOKINASE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THERE WERE NO ERRORS IDENTIFIED IN THE CALIBRATIONS AND QUALITY CONTROLS. A REVIEW OF THE ERROR LOG DID NOT INDICATE AN ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW GLUCOSE HEXOKINASE (GLUH_3) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW GLUH_3 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479119 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR