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	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.No system or reagent abnormalities were observed, and no issues were observed with other patient samples.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 kappa light chains result was obtained on a patient sample on a bn ii system using n antiserum to human ig/l-chain, type kappa reagent using a 1:20 sample dilution.The sample was repeated for kappa light chains using a 1:100 dilution, recovering higher.The sample was then repeated for kappa light chains using a 1:20 dilution, again recovering falsely low.None of the results were reported to the physician(s).The higher result obtained using the 1:100 dilution matched the electrophoresis result for the patient and was considered to be correct.A discordant, falsely low kappa light chains result was obtained on another sample from a different patient on the same bn ii system using n antiserum to human ig/l-chain, type kappa reagent using a 1:20 sample dilution.The sample was repeated for kappa light chains using a 1:100 dilution, recovering higher.The sample was then repeated for kappa light chains using a 1:20 dilution, recovering falsely low.The sample was then repeated for kappa light chains using a 1:400 dilution, recovering falsely low.The following day, the sample was manually diluted 1:2 and was then repeated for kappa light chains using a 1:20 dilution, recovering higher.None of the results were reported to the physician(s).The higher results matched the electrophoresis result for the patient and were considered to be correct.There are no known reports of patient intervention or adverse health consequences due to the falsely low kappa light chains 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
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12939269
• Report Number: 9610806-2021-00072
• Device Sequence Number: 20038639
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown