MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX FLC LAMBDA

Model Number N LATEX FLC LAMBDA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

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.Only one patient sample was affected.The customer followed the guidance in the n latex flc lambda instructions for use (ifu) and repeated the results in a higher sample dilution.According to the n latex flc lambda ifu, the following information should be considered: "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 immune electrophoresis, 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 cause of the event is unknown.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 (flc lambda) result was obtained on a patient sample using a 1:20 dilution on a bn ii system using n latex flc lambda reagent.The result was not reported to the physician(s).The sample was then repeated for flc lambda again using a 1:20 dilution on the same system using the same reagent, recovering higher.This result was not reported to the physician(s).The sample was then repeated for flc lambda using a 1:100 dilution on the same system using the same reagent, recovering higher.This result was not reported to the physician(s).The sample was then repeated for flc lambda using a 1:400 dilution on the same system using the same reagent, recovering higher.This result was reported, as the correct result, to the physician(s).The sample was then repeated for flc lambda using a 1:2000 dilution, recovering higher.This result was not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant free light chains, type lambda (flc lambda) results.

• 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: 12288604
• MDR Text Key: 265414310
• Report Number: 9610806-2021-00054
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K182098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• 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: 42 YR