BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3900981 · Received June 30, 2014

    Report

    Report Number
    2432235-2014-00397
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. THE CSE DETERMINED THAT A SYSTEM DRAIN PUMP (CDP) MALFUNCTIONED DURING THE TIME OF THE EVENT. THE CAUSE OF THE DISCORDANT GLU, E-CREA AND ALB RESULTS WAS DUE TO A CDP PUMP MALFUNCTION. THE CSE REPLACED THE PUMP AND VERIFIED ACCEPTABLE INSTRUMENT FUNCTIONALITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT GLUCOSE (GLU), ENZYMATIC CREATININE (E-CREA) AND ALBUMIN (ALB) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE SYSTEM. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GLUCOSE, ENZYMATIC CREATININE AND ALBUMIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379937 ADVIA 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1