BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630

    MDR report key: 19816470 · Received July 24, 2024

    Report

    Report Number
    9610806-2024-00020
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    UDI-DI
    00630414006239
    PMA / PMN Number
    K001647
    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). OUT OF RANGE QUALITY CONTROLS (QC) WERE OBTAINED ON THE DATE OF THE EVENT. THE OBTAINED QC RESULTS RECOVERED HIGH OUT OF RANGE, BUT RE-TESTING OF THE QC WAS FOUND WITHIN RANGE. NO ISSUES WERE OBSERVED WITH THE SAMPLE KINETICS. A PROBE ON THE ATELLICA NEPH 630 WAS FOUND TO BE LEAKING. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE AND RESOLVED THE ISSUE. NO FURTHER ISSUES HAVE BEEN OBSERVED SINCE THE SERVICE VISIT. HETEROPHILIC ANTIBODIES IN THE SAMPLE OR OTHER PATIENT SAMPLE SPECIFIC ISSUES ALSO CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. 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 WAS INITIALLY CLEARED UNDER PMA/510(K) (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT TWO ERRONEOUS FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA NEPH 630 SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FOLLOW DAY, THE SAMPLES WERE RERAN FOR FLC LAMBDA, AND 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 ERRONEOUS FLC LAMBDA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366463 ATELLICA NEPH 630 ATELLICA NEPH 630 JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH ATELLICA NEPH 630 00630414006239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown