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 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states 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.Mdr 9610806-2023-00003 was filed for the discordant flc lambda result obtained on the atellica neph 630 system using n latex flc lambda reagent (lot 473268).

Event Description

A falsely low free light chains, type lambda (flc lambda) result was obtained on a bn ii system using n latex flc lambda reagent.The sample was repeated on the bn ii system using a 1:100 and 1:2000 sample dilution, again recovering falsely low.The sample was then run for flc lambda on an atellica neph 630 system using an alternate lot of n latex flc lambda reagent, recovering falsely low.None of the discordant results were reported to the physician(s).The sample was then repeated for flc lambda on the atellica neph 630 system using a non-siemens reagent, recovering higher.The higher result matched the patient's electrophoresis result and 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 9610806-2023-00002 on 20-jan-2023.Additional information (27-jan-2023): the affected sample was provided for analysis.It was determined that the sample contained a highly dimerized free light chain, type lambda (flc lambda) molecule.In some patients, flc lambda is skewed towards dimerization, causing the falsely depressed flc lambda results.After reduction of the inter-chain di-sulfide bridges during further investigation, the flc lambda concentration was found to be above the reference interval and comparable to the result obtained using the non-siemens reagent.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2023-00003_s1 was also filed for the incident.

• 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: 16215743
• MDR Text Key: 309048563
• Report Number: 9610806-2023-00002
• Device Sequence Number: 1
• Product Code: DEH
• 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,Followup
• Report Date: 02/21/2023

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: 01/05/2024
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/21/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female