BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYLINK

    MDR report key: 3242349 · Received July 23, 2013

    Report

    Report Number
    2517506-2013-00344
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDQ
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). TSC REMOTELY LOGGED IN AND CHANGED THE SETTINGS TO NO UNIQUE PATIENT ID AND NO PATIENT MATCHING. THE CAUSE OF THE REUSE OF THE SAMPLE ID FOR TWO DIFFERENT PATIENTS WHILE THE SYSTEM WAS CONFIGURED TO MATCH PATIENT ID'S IS A USER ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE EASYLINK INFORMATICS SYSTEM WAS ENABLED BY THE CUSTOMER TO MATCH PATIENTS BY PATIENT ID'S PREVIOUSLY ENTERED INTO THE SYSTEM. THE CUSTOMER PROVIDED A SAMPLE ID AND MANUALLY ENTERED "??" AS A PATIENT ID SINCE THE LAB INFORMATION SYSTEM (LIS) WAS DOWN. SINCE PATIENT ID "??" WAS PREVIOUSLY RECORDED, THE RESULTS WERE SENT AND POSTED UNDER THE WRONG PATIENT. THE ERROR WAS DISCOVERED BASED ON MISMATCHING DEMOGRAPHICS. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342432 EASYLINK INFORMATICS SYSTEM CDQ SIEMENS HEALTHCARE DIAGNOSTICS INC. EASYLINK INFORMATICS SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1