MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX FLC KAPPA

Model Number N LATEX FLC KAPPA

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range.Siemens' investigation determined that the issue was limited to one patient sample.As per the instructions for use (ifu) for n latex flc lambda and n latex flc kappa, "excessively elevated monoclonal immunoglobulin concentrations might have the potential to suppress the reaction of anti-flc antibodies with free light chain molecules.If results do not fit to previous ones, or to results of other tests (e.G.Serum immunoelectrophoresis, immunofixation, differential blood cell count) and/or to the clinical situation, it is recommended to re-analyze the sample in a higher sample dilution.)" the patient's elevated monoclonal immunoglobulin concentrations cannot be ruled out as a cause of the discordant results.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2022-00018 was filed the discordant flc lambda result obtained with n latex flc lambda reagent (lot number: 473264).Mdr 9610806-2022-00019 was filed the discordant flc lambda result obtained with n latex flc lambda reagent (lot number: 473263).

Event Description

A discordant, falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample on a bn ii system (serial number: (b)(4) ) with n latex flc lambda reagent (lot number: 473264) using a 1:5 sample dilution.The sample was then repeated for flc lambda on an alternate bn ii system (serial number: (b)(4) ) with an alternate lot of n latex flc lambda reagent (lot number: 473263) using a 1:2000 sample dilution, recovering falsely low.The discordant results were not reported to the physician(s).The sample was then sent to an alternate laboratory and was run for flc lambda on a bn ii system with a non-siemens reagent using a 1:8000 sample dilution, recovering higher.This higher result was reported, as the correct result, to the physician(s).A discordant, falsely elevated free light chains, type kappa (flc kappa) result was obtained on the same sample on a bn ii system (serial number: (b)(4) ) with n latex flc kappa reagent (lot number: 473164) using a 1:100 sample dilution.The discordant result was not reported to the physician(s).The sample was sent to an alternate laboratory and was run for flc kappa on a bn ii system with a non-siemens reagent using a 1:20 sample dilution, recovering lower.The lower 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 discordant flc lambda and flc kappa results.

• Brand Name: N LATEX FLC KAPPA
• Type of Device: N LATEX FLC KAPPA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14118632
• MDR Text Key: 290532555
• Report Number: 9610806-2022-00020
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K201496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male