BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO LAB DATA MANAGER APPLICATION SOFTWARE

    MDR report key: 3161556 · Received June 11, 2013

    Report

    Report Number
    2517506-2013-00283
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    January 18, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LLZ
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    2517506-05/20/2013-008-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ENTITLED "SYNGO LAB DATA MANAGER VERSION VA11B AND VA12A SYSTEMS: LIMITATIONS AND SOFTWARE ANOMALIES" WAS SENT TO CUSTOMERS IN MAY 2013 TO NOTIFY CUSTOMERS THAT RESULTS MAY NOT BE RECEIVED FROM THE INSTRUMENT OR TRANSFERRED TO THE LABORATORY INFORMATION SYSTEM. THE UMDC PROVIDES CUSTOMERS WITH ACTIONS TO IMPLEMENT WHILE A NEW SOFTWARE VERSION IS DEVELOPED.

    Description of Event or Problem · 1

    THE SYNGO LAB DATA MANAGER SOFTWARE APPLICATION VERSION VA11B DOES NOT SEND ADEQUATE INFORMATION FROM THE ADVIA CENTAUR INSTRUMENT TO THE LABORATORY INFORMATION SYSTEM (LIS), PREVENTING THE LIS FROM CORRECTLY POSTING PATIENT RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO RESULTS NOT BEING CORRECTLY POSTED AT THE LIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262274 SYNGO LAB DATA MANAGER APPLICATION SOFTWARE SYNGO LAB DATA MANAGER APPLICATION SOFTWARE LLZ SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER APPLICATION SOFTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1