BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO LAB DATA MANAGER

    MDR report key: 5065898 · Received September 9, 2015

    Report

    Report Number
    2517506-2015-00181
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    February 10, 2014
    Report Date
    August 20, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JQP
    PMA / PMN Number
    510(K)EXEMPT
    Removal / Correction Number
    2517506-09/01/2015-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS IDENTIFIED FIVE FEATURE ISSUES WITH THE (B)(4) LAB DATA MANAGER. THE ISSUES PERTAIN TO RESULT UNIT CONVERSIONS, QUALITY CONTROL PROCESSING, VIRUS PROTECTION, SYSTEM PERFORMANCE DEGRADATION, AND ORDERS RECEIVED FROM LIS BEING REJECTED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ENTITLED "(B)(4) LAB DATA MANAGER SYSTEM SOFTWARE ISSUES" WAS SENT TO CUSTOMERS IN THE UNITED STATES IN AUGUST 2015. AN URGENT FIELD SAFETY NOTICE (UFSN) ENTITLED "(B)(4) LAB DATA MANAGER SYSTEM SOFTWARE ISSUES" WAS SENT TO CUSTOMERS OUTSIDE OF THE UNITED STATES IN (B)(6) 2015. THE UMDC AND UFSN DESCRIBE THE ISSUES AND PROVIDE ACTIONS THE CUSTOMER CAN TAKE TO PREVENT AND MITIGATE THE ISSUES.

    Description of Event or Problem · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER AT A CUSTOMER SITE DISCOVERED THAT DELETED QUALITY CONTROL (QC) RESULTS ON A (B)(4) LAB DATA MANAGER WOULD COME BACK. WHEN A NEW QC RESULT CONTAINS AN ERROR CODE, THE USER CAN EXCLUDE THE RESULT AND PROCEED WITH RUNNING QC. HOWEVER, IF A SECOND RESULT WITH AN ERROR CODE OCCURS AND THE USER TRIES TO EXCLUDE THE RESULT, THE ERROR FROM THE FIRST QC RESULT REPLACES THE SECOND ERROR. THE USER MUST THEN MANUALLY EXCLUDE THE ERROR RESULT A SECOND TIME. IF THE AUTO VERIFICATION FEATURE IS BEING USED, ALL RESULTS WILL BE HELD. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595158 SYNGO LAB DATA MANAGER CALCULATOR/DATA PROCESSING MODULE JQP SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER

    Patients

    Seq Age Sex Outcome Treatment
    1