BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630

    MDR report key: 19583088 · Received June 21, 2024

    Report

    Report Number
    9610806-2024-00011
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 21, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) WERE FOUND TO HAVE RECOVERED HIGH AND OUTSIDE OF RANGE AT THE TIME OF THE EVENT. THE ATELLICA NEPH 630 SYSTEM ALSO GAVE PROBE LEVEL DETECTION ERRORS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND REPLACED A FLEX CABLE ON THE PROBE ARM, WHICH RESOLVED THE PROBE ERRORS AND PIPETTING ISSUE. THE CUSTOMER ALSO INDICATED THEY ORDERED A NEW LOT OF FLC LAMBDA AND REPLACED THE BUFFER, THE DILUENT AND THE WATER CONTAINERS. NO REAGENT ISSUE WAS IDENTIFIED AND NO GENERAL PERFORMANCE ISSUE FOR THE FLC LAMBDA METHOD WAS IDENTIFIED. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE ATELLICA NEPH 630 SYSTEM WITH CATALOG NUMBER 11239861 DESCRIBED IN SECTION D4 IS NOT MARKETED IN THE UNITED STATES (US) AND THE PMA/510(K) NUMBER (EXEMPT) IN SECTION G5 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 · 0

    THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT FALSELY ELEVATED FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE ELEVATED RESULTS WERE QUESTIONED AND NOT REPORTED AS THEY DID NOT FIT THE HISTORICAL FLC LAMBDA RESULTS FOR THE PATIENTS. THE SAMPLES WERE REPEATED FOR FLC LAMBDA FOUR DAYS LATER USING THE SAME SYSTEM AND REAGENT, RECOVERING LOWER. THE LOWER 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 FALSELY ELEVATED FLC LAMBDA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184418 ATELLICA NEPH 630 ATELLICA NEPH 630 JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH ATELLICA NEPH 630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown