BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 2400

    MDR report key: 2061168 · Received April 18, 2011

    Report

    Report Number
    2432235-2011-00061
    Date Received
    April 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SPECIALIST SPOKE WITH THE CUSTOMER VIA TELEPHONE AT THE TIME THE INCIDENT WAS REPORTED. BASED ON THE REPORTS AND INSTRUMENT DATA PROVIDED BY THE CUSTOMER IT APPEARS THAT THIS WAS AN ISOLATED EVENT AND IT IS UNKNOWN WHAT CAUSED THE DISCORDANT RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA 2400 TOTAL BILIRUBIN (TBIL) WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN. THE SECOND SAMPLE WAS PROCESSED AND A CORRECTED RESULT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TBIL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2400 CHEMISTRY ANALAYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1