BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 10276388 · Received July 15, 2020

    Report

    Report Number
    9610806-2020-00031
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 16, 2020
    Report Date
    August 14, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON 15-JUL-2020. ADDITIONAL INFORMATION (23-JUL-2020): SIEMENS INVESTIGATION DETERMINED THAT LEVEL DETECTION ERRORS OCCURRED ON THE CUSTOMER'S ATELLICA NEPH 630 SYSTEM AT THE TIME OF THE EVENT. THESE LEVEL DETECTION ERRORS LED TO A TERMINATION SAMPLE RESULT PROCESSING, AND, THEREFORE, ARE NOT DIRECTLY RELATED TO THE DISCORDANT RESULTS. HOWEVER, THEY INDICATE A MALFUNCTION OF THE DILUENT PUMP. A SIEMENS CUSTOMER SERVICE ENGINEER REPLACED THE DILUENT PUMP, AFTER WHICH NO OTHER RELATED ERRORS WERE IDENTIFIED. THE CAUSE OF THE ISSUE WAS THE DEFECTIVE DILUENT PUMP. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE DATE OF EVENT IN SECTION B3 HAS BEEN CHANGED FROM (B)(6) 2020 TO (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER NOTICED THAT DILUTIONS WERE NOT BEING CORRECTLY PERFORMED BY THEIR ATELLICA NEPH 630 SYSTEM. THE CUSTOMER FOUND FOAM IN THE DILUTION WELLS AND NOTICED THAT THE DILUENT PUMP WAS LEAKING. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REPLACED THE DILUENT PUMP. SIEMENS IS INVESTIGATING THE ISSUE. THE ATELLICA NEPH 630 SYSTEM WITH CATALOG NUMBER 11239861 DESCRIBED IS NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER IS FOR THE US SIMILAR SYSTEM (BN PROSPEC SYSTEM). THE BN PROSPEC SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10461865 AND ITS UNIQUE DEVICE IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    DISCORDANT KAPPA LIGHT CHAINS AND LAMBDA LIGHT CHAINS RESULTS WERE POTENTIALLY OBTAINED ON PATIENT SAMPLES ON AN ATELLICA NEPH 630 SYSTEM. NO DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739969 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH ATELLICA NEPH 630 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1