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 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states customer contacted a siemens customer care center (ccc).Quality control (qc) results from the day of the event were not provided by the customer.The troubleshooting file provided by the customer did not contain data for the affected patient sample.There was insufficient data provided by the customer to determine the 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.

Event Description

A discordant, falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample run using a 1:20 dilution on a bn ii system using n latex flc lambda reagent.The sample was then repeated for flc lambda using a 1:100 dilution, recovering higher.The sample was then repeated for flc lambda using a 1:400 dilution, recovering falsely elevated.The flc lambda result obtained using the 1:100 dilution was reported, as the correct result, to the physician(s).The sample was then recentrifuged and rerun for flc lambda using a 1:20, 1:100 , and 1:400 dilution.The result obtained using the 1:20 dilution recovered falsely low and the result obtained using the 1:400 dilution recovered falsely elevated.There are no known reports of patient intervention or adverse health consequences due to the discordant 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: 13902789
• MDR Text Key: 287912868
• Report Number: 9610806-2022-00014
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/25/2022

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: 10/29/2022
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473261B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/25/2022
• 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: 59 YR
• Patient Sex: Male