BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 4130077 · Received September 30, 2014

    Report

    Report Number
    2432235-2014-00573
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT THE DAY AFTER THE DISCORDANT RESULT WAS RELEASED, THE OPERATOR NOTICED THAT SODIUM QUALITY CONTROLS (QC) WERE FLAGGED BY THE INSTRUMENT THE PREVIOUS DAY. THE CUSTOMER STATED THAT QC WERE NOT REPEATED OR CALIBRATED AT THE TIME. THE CUSTOMER RECALIBRATED THE ASSAY AND QC WERE WITHIN RANGE. THE CAUSE OF DISCORDANT PATIENT RESULT(S) BEING RELEASED TO THE PHYSICIAN(S) WHILE QC WAS FLAGGED OUT OF RANGE BY THE INSTRUMENT WAS A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM (NA) RESULT WAS OBTAINED ON AN INFANT PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE RESULT DID NOT MATCH THE PATIENT¿S PREVIOUS SODIUM RESULT FROM A SAMPLE TESTED EARLIER THAT DAY, WHICH WAS HIGHER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO ALTERED THE INFANT¿S FLUID MANAGEMENT DRIP. AFTER TROUBLESHOOTING A QUALITY CONTROL ISSUE, THE OPERATOR PERFORMED A LOOK BACK AND REPEATED THE INFANT¿S SAMPLE ON THE SAME INSTRUMENT, WHICH RESULTED HIGHER. A NEW SAMPLE WAS OBTAINED AND TESTED ON THE SAME INSTRUMENT, ALSO RESULTING HIGHER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT DURING THE LOOK BACK TESTING, 15 SAMPLES RESULTED BETWEEN 3 TO 6 UNITS HIGHER. THE CUSTOMER DID NOT PROVIDE PATIENT DATA FOR THOSE SAMPLES. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608098 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1