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	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range and no instrument errors occurred at the time of the event.As per the instruction for use (ifu) for n antiserum to human-ig/l-chain, k-type: the nephelometric determination of human immunoglobulin/ l-chains, types kappa and lambda, cannot replace immunoelectrophoresis or immunofixation electrophoresis in the diagnosis of monoclonal gammopathy.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdr: 9610806-2020-00047 was filed for the results obtained on 20-aug-2020.
Event or Problem Description
A discordant, falsely low kappa light chains result was obtained on a patient sample on a bn ii system using n antiserum to human-ig/l-chain, k-type reagent using a 1:20 sample dilution.The discordant result was not reported to the physician(s).The sample was repeated for kappa light chains using a 1:100 dilution on the same system with the same reagent, recovering higher.The result was reported, as the correct result, to the physician(s).The following day, the same sample was repeated for kappa light chains with the same system and reagent using a 1:20 dilution, recovering lower.This result was considered discordant.The sample was then repeated for kappa light chains using a 1:100 dilution on the same system with the same reagent, recovering higher.This result was considered correct.Neither of these results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low kappa light chains 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: 10540310
• Report Number: 9610806-2020-00046
• Device Sequence Number: 16884591
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 10446594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR