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	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality control (qc) data was not provided by the customer.The calibration curves did not show any abnormalities.The kinetics of the affected sample also did not show any abnormalities.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2022-00052 was filed for the falsely low kappa light chains results obtained on (b)(6) 2022 on the same system.
Event or Problem Description
A falsely low kappa light chains result was obtained on a patient sample using a 1:20 sample dilution on a bn ii system using n antiserum to human ig/l-chain, type kappa reagent.The result was not reported to the physician(s).The sample was repeated for kappa light chains using a 1:100 sample dilution, recovering higher.The 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 falsely low kappa light chains result.

• 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: 15685745
• Report Number: 9610806-2022-00053
• Device Sequence Number: 6443597
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/27/2022

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: 10/08/2022
• Initial Report FDA Received Date: 10/27/2022
• 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