BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 12977187 · Received December 10, 2021

    Report

    Report Number
    9610806-2021-00073
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 16, 2021
    Report Date
    January 7, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2021-00073 ON 10-DEC-2021. ADDITIONAL INFORMATION (13-DEC-2021): THE RESULTS WERE OBTAINED ON 16-NOV-2021, NOT 11-NOV-2021. SECTIONS B3 AND B6 OF THE MDR HAVE BEEN UPDATED TO REFLECT THE CORRECT DATE OF EVENT. ADDITIONAL INFORMATION (21-DEC-2021): SIEMENS HEALTHCARE DIAGNOSTICS FURTHER INVESTIGATED THE ISSUE AND HAS DETERMINED THAT THE ISSUE MAY HAVE BEEN CAUSED BY A SAMPLE TRANSPORT PROBLEM. ALTHOUGH IT IS UNKNOWN IF THE CUSTOMER USED THE CUP-IN-TUBE TO TEST THE SAMPLE, THE ISSUE MAY HAVE BEEN CAUSED BY THE USE OF CUP-IN-TUBE. IF CUP-IN-TUBE IS USED BY THE CUSTOMER, THE INSTRUMENT DOES NOT HAVE THE OPTION OF AUTOMATIC LEVEL DETECTION, AND IMMERSION DEPTH WOULD NEED TO BE SET MANUALLY. IT IS UNKNOWN IF THIS SETTING WAS CORRECTLY CONFIGURED BY THE CUSTOMER. THE CAUSE OF THE EVENT IS UNKNOWN. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. THE INSTRUMENT 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). THE CUSTOMER CLAIMED THAT THE INITIAL RESULTS WERE OBTAINED WITH A LOW VOLUME SAMPLE. SIEMENS IS INVESTIGATING THE ISSUE. 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

    A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT AND A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WERE OBTAINED ON A PATIENT SERUM SAMPLE ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC KAPPA AND N LATEX FLC LAMBDA REAGENTS, RESPECTIVELY. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR FLC KAPPA AND FLC LAMBDA ON THE SAME ATELLICA NEPH 630 SYSTEM USING THE SAME REAGENT, RESULTING HIGHER. THE SAMPLE WAS THEN RUN FOR FLC KAPPA AND FLC LAMBDA ON A NON-SIEMENS ANALYZER, RECOVERING HIGHER AND MATCHING THE HIGHER RESULTS OBTAINED ON THE ATELLICA NEPH 630 SYSTEM. THE HIGHER RESULTS OBTAINED ON THE ATELLICA NEPH 630 SYSTEM 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 LOW FLC KAPPA AND FLC LAMBDA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874926 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male