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

Model Number N LATEX FLC LAMBDA

Device Problem Low Test Results (2458)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.

Event Description

A falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample that was diluted 1:5 on a bn ii system using n latex flc lambda reagent.The sample was rerun using a 1:20 sample dilution for flc lambda on the same system, recovering higher.The sample was then rerun using a 1:100 sample dilution for flc lambda on the same system, recovering higher.The sample was then sent to an alternate laboratory and was run for flc lambda using a non-siemens assay, recovering higher.The higher result obtained using the non-siemens assay 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 lambda results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2023-00008 on 10-mar-2023.Additional information (14-mar-2023): the affected sample was provided for analysis.During internal testing, the sample was rerun for flc lambda with a higher sample dilution, and the flc lambda result recovered higher.It was determined that the sample contained a high level of immunoglobulin a (iga) lambda, which interfered with free light chains, type lambda (flc lambda) measurements at low sample dilutions.As per the n latex flc lambda instructions for use (ifu): "excessively elevated monoclonal immunoglobulin concentrations might have the potential to suppress the reaction of anti-flc antibodies with free light chain molecules.In addition, other conditions may cause lower flc concentrations, e.G., bi-clonal after therapy, polymerization of lambda chains, etc.If results do not fit to previous ones, or to results of other tests (e.G., serum and urine protein electrophoresis, 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 assay performance is in accordance with the ifu.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: N LATEX FLC LAMBDA
• Type of Device: N LATEX FLC LAMBDA
• 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: 16524607
• MDR Text Key: 311502110
• Report Number: 9610806-2023-00008
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 04/03/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 04/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female