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	07/31/2023
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 and there were no issues with other patient samples processed at the time of the event.Siemens is investigating the issue.
Event or Problem Description
A falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample on a bn ii system.The erroneous result was not reported to the physician(s).The sample was repeated two times for flc kappa, recovering higher.The first repeat 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 flc kappa result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2023-00012 on 24-aug-2023.Additional information (30-aug-2023): siemens further evaluated the incident and determined that the calibration curve and quality controls were acceptable when the affected sample was first processed on the bn ii system.Siemens determined that the affected sample showed low raw values during the initial testing.A sample aspiration issue during the initial testing, sample integrity issue, or a sample mismatch potentially contributed to the unexpected low raw values.A reagent issue was ruled out as quality controls recovered in range and no issues were reported with other patient samples.The investigation findings and investigation conclusions codes in section h6 were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• 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 3003601075; am kronberger hang 3; schwalbach 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 17619012
• Report Number: 9610806-2023-00012
• Device Sequence Number: 11424428
• Product Code: DEW
• 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,Followup
• Report Date (Section B): 09/25/2023

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): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/25/2023
• 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 Age: 61 YR
• Patient Sex: Female