BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 14517659 · Received May 26, 2022

    Report

    Report Number
    9610806-2022-00038
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 26, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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). QUALITY CONTROLS (QC) HAD RECOVERED OUT OF RANGE AT THE TIME OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) DETERMINED THAT A SYSTEM WASTE PUMP HAD FAILED, AND THE CSE REPLACED THE PUMP. THE WASTE PUMP HAD BEEN INSTALLED IN FEBRUARY OF 2021 AND WAS OVER THE EXPECTED LIFETIME OF THIS PART OF ONE YEAR. THE SYSTEM WAS RETURNED TO NORMAL OPERATION AFTER THE WASTE PUMP WAS REPLACED. HOWEVER, NO RELATIONSHIP BETWEEN THE FAILED WASTE PUMP AND THE DISCORDANT PATIENT SAMPLE RESULTS COULD BE IDENTIFIED. THE CAUSE OF THE DISCORDANT RESULTS IS UNKNOWN. 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)(6) AND THE PMA/510(K) K001647.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY LOW KAPPA LIGHT CHAINS RESULT AND A DISCORDANT, FALSELY ELEVATED LAMBDA LIGHT CHAINS RESULT WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAMPLE WAS REPEATED FOR KAPPA LIGHT CHAINS AND LAMBDA LIGHT CHAINS. THE KAPPA LIGHT CHAINS RESULT RECOVERED HIGHER AND THE LAMBDA LIGHT CHAINS RESULT RECOVERED LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT KAPPA LIGHT CHAINS AND LAMBDA LIGHT CHAINS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711557 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male