BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 2400

    MDR report key: 2060341 · Received April 16, 2011

    Report

    Report Number
    2432235-2011-00043
    Date Received
    April 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER ) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT GLUCOSE RESULTS WAS UNKNOWN. THE FSE PROACTIVELY REPLACED THE REAGENT PROBE PIPETTE 1 (RPP1), CHECKED AND ADJUSTED MECHANICAL ALIGNMENTS AND FLUSHED NOZZLE 1 WITH WATER. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS NEEDED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA 2400 GLUCOSE RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES. THE LABORATORY REPEATED THE SAMPLES ON AN ADVIA 1800 SYSTEM AND REPORTED THE CORRECTED RESULTS TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2400 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1