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 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report a discordant, falsely low free light chains, type lambda (flc lambda) result obtained on a patient sample on an atellica neph 630 system using n latex flc lambda reagent.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 an atellica neph 630 system using n latex flc lambda reagent.The discordant result was not reported to the physician(s).The sample was then analyzed using both electrophoresis and immunofixation tests.Lambda light chains were observed using both tests.A higher flc lambda result would be expected based on the electrophoresis and immunofixation tests.There are no known reports of patient intervention or adverse health consequences due to the falsely low flc lambda result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00077 on (b)(6)2021.Additional information (21-dec-2021): siemens requested system data files, but the customer did not provide the requested information.No data analysis was possible since the customer declined to provide additional information.The cause of the event is unknown.The investigation findings and investigation conclusions codes in h6 were updated to reflect the additional information.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: 13025045
• MDR Text Key: 290148900
• Report Number: 9610806-2021-00077
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 01/07/2022

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: 03/08/2022
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473260A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/07/2022
• 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