BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO BY SIEMENS

    MDR report key: 8724381 · Received June 21, 2019

    Report

    Report Number
    2517506-2019-00258
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 21, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LXG
    UDI-DI
    00630414596754
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CUSTOMER SITE VISIT BY SIEMENS PERSONNEL, IT WAS OBSERVED THAT THE CUSTOMER WAS OPERATING AN APTIO BY SIEMENS SYSTEM ATTACHED TO ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WITH THE PROTECTIVE COVERS REMOVED. THIS CONFIGURATION PERMITS ACCESS TO TUBES THAT ARE MOVING IN THE SHC AND OVER-RIDES THE COVER INTERLOCKS. SIEMENS PERSONNEL INSTRUCTED THE CUSTOMER TO OPERATE THE INSTRUMENT WITH THE COVERS IN PLACE, IN ACCORDANCE WITH THE OPERATOR GUIDE FOR THE APTIO BY SIEMENS SYSTEM. THE CAUSE OF OPERATING AN APTIO BY SIEMENS AUTOMATION SYSTEM ATTACHED TO AN ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WITH THE COVERS REMOVED IS A USE ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS NEEDED. MDR 2432235-2019-00218 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    AN APTIO BY SIEMENS SYSTEM ATTACHED TO AN ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WAS BEING OPERATED WITH THE PROTECTIVE COVERS REMOVED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO OPERATING AN APTIO BY SIEMENS SYSTEM ATTACHED TO AN ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT WITH THE PROTECTIVE COVERS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516488 APTIO BY SIEMENS APTIO BY SIEMENS LXG SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO BY SIEMENS 00630414596754

    Patients

    Seq Age Sex Outcome Treatment
    1