BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA NEPH 630 SYSTEM

    MDR report key: 13573176 · Received February 21, 2022

    Report

    Report Number
    9610806-2022-00010
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    January 26, 2022
    Report Date
    May 6, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). THE DAY PRIOR TO THE EVENT, THE CUSTOMER HAD TAKEN THE SAMPLE ROTOR OUT TO CLEAN IT DUE TO A SAMPLE RACK BARCODE READING ISSUE. QUALITY CONTROLS RECOVERED IN RANGE ON THE DAY OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE THE DAY AFTER THE EVENT. THE CSE PERFORMED TROUBLESHOOTING AND IDENTIFIED A WRONG ADJUSTMENT OF THE SAMPLE ROTOR. THE OUTER RACK POSITION OF THE SAMPLE TUBES WAS INCORRECTLY ADJUSTED BY THE CUSTOMER AND CAUSED THE WRONG SAMPLE POSITION TO BE PIPETTED (POSITION 3 INSTEAD OF POSITION 1, POSITION 5 INSTEAD OF POSITION 3, AND SO ON). ONLY THE SAMPLES WHICH WERE MEASURED IN THE OUTER RACK POSITION WERE AFFECTED. THE INNER RACK POSITION WAS NOT AFFECTED BY THIS INCORRECT ADJUSTMENT. CONTROL RESULTS WERE NOT AFFECTED BY THIS ISSUE AS THEY WERE PIPETTED FROM THE REAGENT ROTOR AND NOT FROM THE SAMPLE ROTOR. 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.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2022-00010 ON 21-FEB-2022. ADDITIONAL INFORMATION (14-APR-2022): SIEMENS ANALYZED THE PROVIDED SYSTEM TROUBLESHOOTING FILES, BUT BACKUPS FROM THE TIME WHEN THE ISSUE OCCURRED WERE NO LONGER AVAILABLE. SIEMENS INVESTIGATED THE POSSIBLE SEQUENCE OF EVENTS WHICH COULD LEAD TO THE ISSUE AND DETERMINED THAT A VERY RARE COMBINATION OF TECHNICAL ISSUES AND SUBSEQUENT SERVICE ACTIVITIES MAY HAVE CONTRIBUTED TO THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER'S ATELLICA NEPH 630 SYSTEM PIPETTED 8 PATIENT SAMPLES FROM THE INCORRECT SAMPLE TUBE. DISCORDANT FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA), FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA), CERULOPLASMIN, SOLUBLE TRANSFERRIN RECEPTOR (STFR), ALBUMIN, IMMUNOGLOBULIN A (IGA), IMMUNOGLOBULIN G (IGG), AND IMMUNOGLOBULIN M (IGM) RESULTS WERE OBAINED DUE TO THE INCORRECT SAMPLE TUBES BEING ASPIRATED. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE FOLLOWING DAY, THE SAMPLES WERE REPEATED AND WERE CORRECTLY SAMPLED BY THE SYSTEM. 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 PIPETTING OF THE INCORRECT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120399 ATELLICA NEPH 630 SYSTEM ATELLICA NEPH 630 SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown