BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 12862101 · Received November 23, 2021

    Report

    Report Number
    9610806-2021-00071
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 1, 2021
    Report Date
    December 22, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2021-00071 ON 23-NOV-2021. ADDITIONAL INFORMATION (30-NOV-2021): QUALITY CONTROLS (QC) RECOVERED IN RANGE AND THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. NO INSTRUMENT ISSUES WERE OBSERVED BASED ON THE SYSTEM LOG FILES PROVIDED BY THE CUSTOMER. SAMPLE INTEGRITY ISSUES AND PREANALYTICAL VARIABLES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE CHANGED THE PROBE, SYRINGE, BUFFER PUMP, PUMP SYSTEM LIQUID, AND WASH STATION DILUENT VALVE. THE CSE ADJUSTED THE SYSTEM PROBE, PUMPS AND OPTICS. THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. 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 · 0

    A DISCORDANT, FALSELY ELEVATED FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR FLC KAPPA ON AN ALTERNATE ATELLICA NEPH 630 SYSTEM, RECOVERING LOWER. THE LOWER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED FLC KAPPA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759034 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 49 YR Male