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 10/26/2022

Event Type  malfunction  

Event Description

A falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample run in a 1:20 dilution on bn ii system using n latex flc lambda reagent.The sample was then repeated for flc lambda using a 1:5 manual sample dilution, also recovering low.The sample was then repeated for flc lambda using a 1:400 manual sample dilution, recovering higher.The sample was then repeated for flc lambda using a 1:2000 manual sample dilution, recovering higher and fitting the patient's electrophoresis result.The flc lambda result obtained with the 1:2000 dilution 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

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The customer did not provide the requested troubleshooting files for siemens to evaluate.As per the instructions for use (ifu) for n latex flc lambda: "excessively elevated monoclonal immunoglobulin concentrations might have the potential to suppress the reaction of anti-flc antibodies with free light chain molecules".A patient sample specific issue 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: 15847283
• MDR Text Key: 307894507
• Report Number: 9610806-2022-00055
• 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
• Report Date: 11/22/2022

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: 09/22/2023
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473268A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/22/2022
• 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: 58 YR
• Patient Sex: Female