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)
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.Siemens is investigating the issue.The date of event in section b3 was left blank as the customer indicated that the low results were first observed on (b)(6) 2023 but did not specify the dates for the results in section b6.
Event or Problem Description
Low free light chains, type kappa (flc kappa) results were obtained on five patient samples and a low free light chains, type lambda (flc lambda) result was obtained on a patient sample on a bn ii system using n latex flc kappa reagent and n latex flc lambda reagent.The samples were also run using immunofixation which showed positive m-bands for kappa and lambda.There are no known reports of patient intervention or adverse health consequences due to the low flc kappa and flc lambda.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00103 on 18-may-2023.Additional information (05-jun-2023): the customer name and phone number were updated in section e1.Calibration and quality controls (qc) data were valid on the day of the event.As per the n latex flc kappa n latex flc lambda instructions for use (ifu): "excessively elevated monoclonal immunoglobulin concentrations might have the potential to suppress the reaction of anti-flc antibodies with free light chain molecules.In addition, other conditions may cause lower flc concentrations, e.G., bi-clonal after therapy, polymerization of lambda chains, etc.If results do not fit to previous ones, or to results of other tests (e.G., serum and urine protein electrophoresis, immunofixation, differential blood cell count) and/or to the clinical situation, it is recommended to re-analyze the sample in a higher sample dilution.Such samples may also not dilute in a linear fashion." sample specific issues cannot be ruled out as potential causes of the event.The investigation findings and investigation conclusion in section h6 was updated to reflect the additional information.Mdr 2432235-2023-00102 and supplemental mdr 2432235-2023-00102_s1 were also filed for this event.

• 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 35041 ; GM 35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number 3003601075; am kronberger hang 3; schwalbach 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16956961
• Report Number: 2432235-2023-00103
• Device Sequence Number: 12515725
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 06/30/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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