BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3203042 · Received July 2, 2013

    Report

    Report Number
    2432235-2013-00301
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CALCIUM RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00301 WAS FILED ON JULY 2, 2013. AN ADDITIONAL DISCORDANT, FALSELY LOW CALCIUM RESULT WAS OBTAINED FOR PATIENT SID (B)(6) ON THIS ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON ANOTHER ANALYZER AND RESULTED HIGHER THAN THE INITIAL RESULT. IT IS UNKNOWN IF THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULT. (B)(6). DURING TROUBLESHOOTING THE FSE DISCOVERED A LEAK IN THE DAILY CLEANING PROCEDURE (DCP) PUMP, CLEANED THE APERTURE LENSES AND DRYER TIP NOZZLES, PRIMED THE SYSTEM AND REPLACED THE PUMP SEALS FOR THE DCP AND DILUTION OUTPUT PUMP (DOP) PUMP, THE TUBING CONNECTOR WHERE THE DCP LEAK WAS LOCATED, THE OIL BATH AND FILTER AND SIX PUMPS [SAMPLE PUMP (SP), DILUTION INPUT PUMP (DIP) - TWICE, DILUTION OUTPUT PUMP (DOP), SAMPLE REAGENT WASH PUMP (SRWP), REAGENT PROBE (RPP) 1 PUMP AND THE REAGENT PROBE (RPP) 2 PUMP]. AN INSTRUMENT CONSULTANT WAS ALSO DISPATCHED TO THE CUSTOMER SITE AND THE DILUTION LINE WAS DECONTAMINATED WITH BLEACH AND THE DPEV-1 VALVE, DILUTION CHECK VALVE, CLOT CONTROLLER BOARD (PCB), CUVETTES AND THE DIP (LATER REMOVED) WERE REPLACED. QUALITY CONTROLS WERE RUN, ALL OF WHICH WERE IN RANGE. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CALCIUM RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE AUTO REPEAT RESULTED LOWER. THE SAMPLE WAS RERUN ON THIS INSTRUMENT AND RESULTED HIGHER AND THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303102 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1