MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN II SYSTEM

Model Number	BN II SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens could not fully investigate this event as the customer did not provide the system log files from 20-mar-2021.There is no indication of a potential performance issue with the instrument or the reagent.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample using a 1:100 dilution on a bn ii system using n latex flc kappa reagent.The sample was then repeated two more times using a 1:20 dilution, also recovering falsely low.None of the discordant results were reported to the physician(s).Two days later, the sample was repeated using a 1:2000 dilution, recovering higher.This higher result was reported, as the correct result, to the physician(s).A discordant, falsely low free light chains, type lambda (flc lambda) result was obtained on the same patient sample on the same bn ii system using n latex flc lambda reagent.The discordant result was not reported to the physician(s).Two days later, the sample was repeated for flc lambda, recovering higher.This higher result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc kappa and flc lambda results.

• Brand Name: BN II SYSTEM
• Common Device Name: BN II SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11678835
• Report Number: 9610806-2021-00040
• Device Sequence Number: 14509286
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943997
• 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): 04/16/2021

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: BN II SYSTEM
• Device Catalogue Number: 11254820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR