BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SOLUTION

    MDR report key: 8724382 · Received June 21, 2019

    Report

    Report Number
    2432235-2019-00218
    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
    JJE
    UDI-DI
    00630414002439
    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 ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT ATTACHED TO AN APTIO BY SIEMENS AUTOMATION SYSTEM 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 ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT. THE CAUSE OF OPERATING THE ATELLICA SAMPLE HANDLER PRIME SAMPLE HANDLER CONNECT (SHC) INSTRUMENT ATTACHED TO AN APTIO BY SIEMENS AUTOMATION SYSTEM WITH THE COVERS REMOVED IS A USE ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS NEEDED. MDR 2517506-2019-00258 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516184 ATELLICA SOLUTION ATELLICA SOLUTION JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1