BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 2400

    MDR report key: 1894882 · Received November 5, 2010

    Report

    Report Number
    2432235-2010-00153
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 6, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS NOT SENT TO THE CUSTOMER SITE. THERE IS NO RECORD OF A SYSTEM MALFUNCTION AND NO RECORD OF ANY SPECIFIC PROBLEMS WITH THE INSTRUMENT. THIS ISSUE HAS BEEN CLASSIFIED AS AN ISOLATED EVENT. THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM, CHLORIDE AND POTASSIUM RESULTS WERE OBTAINED ON AN ADVIA 2400 FOR ONE PT. THE RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDER. THE PT SAMPLES WERE REPEATED ON ANOTHER ADVIA 2400 SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THE PT WAS PREGNANT AND NEAR-TERM WITH SEVERE EDEMA. THE FALSELY RESULTS MAY NOT HAVE CONTRIBUTED TO THE DIAGNOSIS OF PRE-ECLAMPSIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1