BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3972449 · Received July 31, 2014

    Report

    Report Number
    2432235-2014-00456
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 ADJUSTED THE DILUTION PROBE PIPETTE (DPP) ALIGNMENT AND VERIFIED THE PROBE HEIGHT. THE CSE CHECKED THE LOW LIGHT SIGNAL AMPLIFIER CONNECTIONS AND VERIFIED PROPER DPP SAMPLING. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN QUALITY CONTROLS AND VERIFIED PROPER SYSTEM FUNCTIONALITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT GLUCOSE (GLU), UREA NITROGEN (BUN), CREATININE (CREA), TOTAL PROTEIN (TP), ALBUMIN (ALB), CALCIUM_2 (CA_2), ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE (AST), ALKALINE PHOSPHATASE (ALP) AND CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT (GLU), (BUN), (CREA), (TP), (ALB), (CA_2), (ALT), (AST), (ALP) AND (CO2) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446862 ADVIA 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1