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	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.The cse checked the sample probe adjustment in lane 3 of the bn ii system and did not observe any issues.No problems were observed with the solenoid valves, the cuvettes had been changed every two weeks, and the water tank did not show any contamination.Quality controls (qc) also recovered within range at the time of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00054 was filed for the discordant results obtained on (b)(6) 2020.Mdr 9610806-2020-00055 was filed for the discordant results obtained on (b)(6) 2020.
Event or Problem Description
A discordant, falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample on a bn ii system using n latex flc kappa reagent.The discordant result was not reported to the physician(s).The sample was repeated two times the same day for flc kappa using a 1:400 dilution, recovering higher than the initial result.The sample was then repeated again the same day for flc kappa using a 1:2000 dilution, recovering higher.The flc kappa result obtained with the 1:2000 dilution was reported to the physician(s).The following day, the same sample was repeated again for flc kappa and exhibited the same behavior as the day before.Eight days later, the sample was repeated six times for flc kappa using a 1:100, 1:400, 1:2000, 1:8000, 1:40000, and 1:160000 dilution, recovering progressively higher with each dilution.The result obtained with the 1:160000 dilution was considered correct.None of the results obtained on this day were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low flc kappa 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
• MDR Report Key: 10803679
• Report Number: 9610806-2020-00056
• Device Sequence Number: 3883886
• Product Code: JQX
• UDI-Device Identifier: 00630414002903
• UDI-Public: 00630414002903
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1