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	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Prior to this event occurring, the sample probe had been damaged due to loading of capped sample.A siemens customer service engineer (cse) had replaced the sample probe module and qc recovered acceptably.However, following this probe replacement, increased lightning bolt errors were observed.Quality controls (qc) sporadically recovered out of range on the day of the event.Review of error logs reveals a high frequency of liquid level detection (lld) errors on the sample probe.A siemens cse was sent onsite and again replaced the sample probe assembly.Post service qc was verified to be within expected ranges.Replacing the sample probe a second time returned the system to normal operation.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Falsely low free light chains, type lambda (flc lambda) results were obtained on multiple patient samples on a bn ii system using n latex flc lambda reagent.The erroneous results were reported to the physician(s).The samples were repeated for flc lambda on an alternate bn ii system, recovering higher.The customer contacted the physician(s) about the event and reported the repeat results, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely low 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
• 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: 18185703
• Report Number: 9610806-2023-00021
• Device Sequence Number: 6503801
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/21/2023

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: 10/31/2023
• Initial Report FDA Received Date: 11/21/2023
• 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