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 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.The issue is limited to one patient serum sample.No assay related product non-conformance was identified.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low free light chains, type lambda result was obtained on a bn ii system using n latex flc lambda reagent.The discordant result was reported and questioned by the physician(s).The sample was repeated for free light chains, type lambda on the bn ii system using binding site reagent, resulting higher.This result was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low free light chains, type lambda result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00045 on 08-sep-2020.Additional information (02-oct-2020): section d8 of the mdr was changed from "unknown" to "no".

• 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
• MDR Report Key: 10503513
• MDR Text Key: 214805524
• Report Number: 9610806-2020-00045
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• PMA/PMN Number: K182098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: 03/01/2021
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR