BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 10968075 · Received December 8, 2020

    Report

    Report Number
    9610806-2020-00061
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 8, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED WITHIN RANGE AT THE TIME OF THE EVENT. NO OTHER PATIENT SAMPLES WERE AFFECTED AND THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. THE REPEAT MEASUREMENT OF THE SAME SAMPLE USING THE SAME SYSTEM AND REAGENT RECOVERED ACCEPTABLY. THE CAUSE OF THE EVENT IS UNKNOWN. 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 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 · 1

    A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE USING A 1:5 DILUTION ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR FLC LAMBDA ON THE SAME SYSTEM WITH THE SAME REAGENT USING A 1:32000 DILUTION, RESULTING HIGHER. THIS RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC LAMBDA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432469 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 67 YR