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 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.Siemens is investigating the issue.

Event Description

A discordant, falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system using n latex flc lambda reagent.The sample was manually diluted and rerun for flc lambda, recovering higher.Both the initial and diluted results were reported to the physician(s).The patient's immunofixation showed a recognizable band of free light chains.The higher result was considered to be the correct result as it matched with the immunofixation.The sample was then sent to an alternate laboratory and was run for flc lambda on an unknown instrument, recovering higher than either of the results obtained on the bn prospec system.This result was considered to be too high and was not considered to be correct.There are no known reports of patient intervention or adverse health consequences due to the discordant flc lambda result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2022-00048 on 16-sep-2022.Additional information (26-sep-2022): siemens' investigation has determined that in patients with amyloidosis, free light chains type lambda (flc lambda) can form polymers in high concentrations.The siemens flc lambda epitopes become inaccessible during polymer formation and can cause a negative result.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.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 customer also established a reference curve with n flc standard sl lot 473457 which had already expired at the time of measurement.Expired reagents must not be used.Thus, patient results should not have been reported using this calibration.The use error cannot be ruled out as a potential cause of the event.The cause of the event is unknown.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: 15440072
• MDR Text Key: 303924615
• Report Number: 9610806-2022-00048
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473267A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• 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: 44 YR
• Patient Sex: Male