BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYLINK

    MDR report key: 4278198 · Received November 25, 2014

    Report

    Report Number
    2517506-2014-00360
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 31, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    510(K)EXEMPT
    Removal / Correction Number
    2517506-05/07/2015-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. THE HSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE EASYLINK DATABASE DRIVER HAD A DEADLOCK AND WAS UNABLE TO READ OR WRITE DATA IN THE SYSTEM DATABASE. THE HSC DETERMINED THAT WHEN THIS OCCURS, THE EASYLINK WILL ALERT THE USER BY DISPLAYING A SYSTEM ALERT IN THE RESULT MANAGER SCREEN. THE USER IS ABLE TO ACCESS THE ERROR LOGS WITHIN THE EASYLINK COMMUNICATIONS DIRECTORY AND DETERMINE IF THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CAUSE OF THE DATABASE DRIVER DEADLOCK IS UNKNOWN. THE CUSTOMER REPORTED A CORRECTED RESULT TO THE PHYSICIAN(S). THE HSC DETERMINED THAT THE EASYLINK RULES ARE FUNCTIONING CORRECTLY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2014-00360 WAS FILED WITH THE FDA ON NOVEMBER 25, 2014. CORRECTED DATA: INITIAL MDR INCORRECTLY LISTS THE 510(K) NUMBER AS K051087. EASYLINK DATA MANAGEMENT SYSTEM IS 510 (K) EXEMPT. ADDITIONAL INFORMATION (4/24/2015): SIEMENS HEALTHCARE DIAGNOSTICS HAS RECEIVED COMPLAINTS REGARDING REFERENCE RANGES, SAMPLE REPORTS, USER-INITIATED SAMPLE/RESULT ACTIONS, AND AUTO-VERIFICATION AND QUALITY CONTROL PROCESSING FOR THE EASYLINK¿ DATA MANAGEMENT SYSTEM SOFTWARE. THROUGH INTERNAL INVESTIGATION, SIEMENS HAS CONFIRMED ISSUES WITH: CUSTOM REFERENCE RANGES, USER-INITIATED SAMPLE AND RESULT ACTIONS, AUTO-VERIFICATION AND QUALITY CONTROL RULES, AND SAMPLE REPORTS. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ENTITLED "EASYLINK DATA MANAGEMENT SYSTEM LIMITATIONS AND SOFTWARE ISSUES" WAS SENT TO CUSTOMERS IN THE UNITED STATES AND AN URGENT FIELD SAFETY NOTICE (UFSN) ENTITLED "EASYLINK DATA MANAGEMENT SYSTEM LIMITATIONS AND SOFTWARE ISSUES" WAS SENT TO CUSTOMERS OUTSIDE THE UNITED STATES IN MAY 2015. THE UMDC/UFSN EXPLAIN THE REASON FOR THE CORRECTION AND ACTIONS CUSTOMERS CAN TAKE TO PREVENT THESE ISSUES FROM OCCURRING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ADVIA CENTAUR INSTRUMENT OBTAINED A DOSE PATIENT RESULT, WHICH WAS SENT TO THE EASYLINK SYSTEM. THE EASYLINK SYSTEM RELEASED A DISCORDANT COEFFICIENT OF ONE RESULT TO THE PHYSICIAN(S) LABORATORY INFORMATION SYSTEM, WHICH DID NOT INCLUDE THE WORD "DOSE". A CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PHYSICIAN(S) CONTACTED THE PATIENT, ADVISING THEM THEY WERE NOT IN REMISSION. THERE ARE NO REPORTS OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DOSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765707 EASYLINK INFORMATICS SYSTEM JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. EASYLINK INFORMATICS SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1