MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH ATELLICA NEPH 630 SYSTEM

Model Number	ATELLICA NEPH 630 SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center suspecting a broken/defect diluent pump in the system.A siemens customer service engineer (cse) was dispatched to the customer site.Quality controls (qc) recovered in range at the time of the event.It was found that the diluent pump of the customer's atellica neph 630 system sporadically stopped pumping liquid.Additionally, crystallization built up on the outside of the dilution pump head.The diluent pump was replaced by the cse.The cause of the event was the defective diluent pump.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).
Event or Problem Description
Discordant, falsely elevated kappa light chains, lambda light chains, and albumin results were obtained on five cerebrospinal fluid (csf) patient samples from four different patients on an atellica neph 630 system.It is unknown if the discordant results were reported to the physician(s).The following day, the samples were repeated for kappa light chains, lambda light chains, and albumin, respectively, all of which recovered lower.The lower repeat results were considered to be the correct results.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated kappa light chains, lambda light chains, and albumin results.

• Brand Name: ATELLICA NEPH 630 SYSTEM
• Common Device Name: ATELLICA NEPH 630 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10993897
• Report Number: 9610806-2020-00063
• Device Sequence Number: 830484
• Product Code: JZW
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K001647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATELLICA NEPH 630 SYSTEM
• Device Catalogue Number: 11239861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1