BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 14254871 · Received April 29, 2022

    Report

    Report Number
    9610806-2022-00021
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 29, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE CONFIRMED THAT THE ATELLICA NEPH 630 SYSTEM DILUENT PUMP FAILED DUE TO SPORADIC INADEQUATE OUTPUT VOLUME. THE FAILURE WAS FOUND TO HAVE OCCURRED ON (B)(6) 2022. AFTER REPLACING THE DILUENT PUMP, QUALITY CONTROLS (QC) RECOVERED ACCEPTABLY AND THE SYSTEM WAS OPERATIONAL. THE CAUSE OF THE EVENT WAS THE DILUENT PUMP FAILURE. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE ATELLICA NEPH 630 SYSTEM IS NOT MARKETED IN THE UNITED STATES (US).THIS MDR IS FILED FOR THE US SIMILAR SYSTEM (BN PROSPEC SYSTEM). THE BN PROSPEC SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10461865, UNIQUE DEVICE IDENTIFIER (B)(4) AND THE PMA/510(K) K001647.

    Description of Event or Problem · 0

    TWO DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULTS AND A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC KAPPA AND N LATEX FLC LAMBDA REAGENTS, RESPECTIVELY. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SUBSEQUENTLY HAD A BONE MARROW BIOPSY PERFORMED AS WELL AS A CT SCAN. FIVE DAYS LATER, THE SAME SAMPLE WAS REPEATED FOR FLC KAPPA AND FLC LAMBDA AFTER THE ATELLICA NEPH 630 SYSTEM DILUENT PUMP WAS REPLACED. THE FLC KAPPA AND FLC LAMBDA RESULTS RECOVERED LOWER. THE LOWER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT AND TWO DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE FROM ANOTHER PATIENT ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC KAPPA AND N LATEX FLC LAMBDA REAGENTS, RESPECTIVELY. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SUBSEQUENTLY HAD A CT SCAN. FIVE DAYS LATER, THE SAME SAMPLE WAS REPEATED FOR FLC KAPPA AND FLC LAMBDA AFTER THE ATELLICA NEPH 630 SYSTEM DILUENT PUMP WAS REPLACED. THE FLC KAPPA AND FLC LAMBDA RESULTS RECOVERED LOWER. THE LOWER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FLC KAPPA AND FLC LAMBDA RESULTS OR DUE TO THE BONE MARROW BIOPSY AND CT SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438272 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown