BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 10843825 · Received November 16, 2020

    Report

    Report Number
    9610806-2020-00057
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 19, 2020
    Report Date
    March 19, 2021
    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 · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2020-00057 ON 16-NOV-2020. ADDITIONAL INFORMATION (22-FEB-2021): CUSTOMER NOTIFICATIONS PP-21-002 A OUS ("ATELLICA NEPH 630 SYSTEM - NON-FUNCTIONING CUVETTE HEATING") AND PP-21-002 B OUS ("BN PROSPEC SYSTEM - NON-FUNCTIONING CUVETTE HEATING") WERE SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN FEBRUARY 2021 AND CUSTOMER NOTIFICATION PP-21-002 C OUS ("BN PROSPEC SYSTEM - NON-FUNCTIONING CUVETTE HEATING") WAS SENT TO OUS CUSTOMERS IN MARCH 2021. THE CUSTOMER NOTIFICATIONS EXPLAIN THE THAT THE CUVETTE HEATING ON ROHS ATELLICA NEPH 630 SYSTEMS AND ROHS BN PROSPEC SYSTEMS MAY SPORADICALLY NOT WORK AS INTENDED AFTER START OR INITIALIZATION OF THE INSTRUMENT WITHOUT ANY VISIBLE NOTIFICATION FOR CUSTOMERS. THE CUSTOMER NOTIFICATIONS EXPLAIN HOW TO IDENTIFY IF THE CUVETTE HEATING IS WORKING AND RECOMMEND A RE-START OR RE-INITIALIZATION OF THE SYSTEM TO RESOLVE THE ISSUE. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR. THE ISSUE ONLY AFFECTS ROHS ATELLICA NEPH 630 SYSTEMS AND ROHS BN PROSPEC SYSTEMS, BOTH OF WHICH ARE NOT MARKETED IN THE US.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS DID NOT RECOVER IN RANGE ON (B)(6) 2020. AFTER ASSAY RECALIBRATION, CONTROLS RECOVERED WITHIN RANGE. QUALITY CONTROLS AGAIN DID NOT RECOVER IN RANGE (B)(6) 2020. THE CUSTOMER CHANGED THE CUVETTES ON THE ATELLICA NEPH 630 SYSTEM AND REALIZED THAT THE CUVETTES WERE COLD. THE CUSTOMER REALIZED HE WAS ALSO WORKING WITH COLD CUVETTES THE DAY BEFORE. THE SYSTEM LOG FILES PROVIDED BY THE CUSTOMER ONLY DATE BACK TO (B)(6) 2020. THE SYSTEM REGULARLY REPORTED A TEMPERATURE OF 37 ¿C AS OF (B)(6) 2020 AT 12:12 PM, WHICH WAS WHEN THE SYSTEM WAS LAST RESTARTED BY THE CUSTOMER. THE SYSTEM IS SPECIFIED TO MAINTAIN THE CUVETTE ROTOR TEMPERATURE AT APPROXIMATELY 37 ¿C (37.3¿C ¿1¿CELSIUS) DURING MEASUREMENTS. UP UNTIL (B)(6) 2020 (WHICH WAS THE LAST DATE FOR WHICH LOG FILES WERE PROVIDED), ALL SYSTEM STATE CHANGES FROM OR TO STANDBY WERE ACCOMPANIED RESPECTIVELY BY A PROPER SWITCH ON OR OFF OF THE HEATER FOR THE CUVETTE ROTOR. THE CAUSE OF THE SPORADIC FAILURE OF THE HEATER FOR THE CUVETTE ROTOR COULD NOT BE DETERMINED. THE CAUSE OF THE DISCORDANT FREE LIGHT CHAINS, TYPE LAMBDA RESULTS WAS THE CUVETTE HEATING FAILURE. 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

    DISCORDANT FALSELY ELEVATED FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC LAMBDA REAGENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE FOUR SAMPLES WERE REPEATED FOR FLC LAMBDA, RESULTING LOWER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312548 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