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

Model Number N LATEX FLC KAPPA

Device Problem Low Test Results (2458)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

A falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample using a 1:100 sample dilution on a bn ii system using n latex flc kappa reagent.The erroneous result was not reported to the physician(s).The sample was repeated for flc kappa using a 1:400 dilution and the result recovered higher but still falsely low.The sample was then repeated for flc kappa using a 1:2000 dilution, and the result recovered higher.This result was reported, as the correct result, to the physician(s).The sample was repeated for flc kappa one additional time using a 1:8000 dilution but a specific numeric result was not generated.There are no known reports of patient intervention or adverse health consequences due to the erroneous flc kappa results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The troubleshooting file provided did not contain the affected patient sample result data.Siemens was not able to perform troubleshooting and evaluate the erroneous results.Quality control (qc) data was also not provided.No other erroneous results were obtained, neither for free light china, type kappa (flc kappa) nor for any other method, and no issue with the assay or system was identified.A patient sample specific issue cannot be ruled out as a potential cause of the event.However, this cannot be clarified due to lack of information.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.The n latex flc kappa reagent is marketed in the united states under material number 10873629.The 510(k) number documented in section g4 is for this product.

• Brand Name: N LATEX FLC KAPPA
• Type of Device: N LATEX FLC KAPPA
• 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: 18915348
• MDR Text Key: 337819948
• Report Number: 9610806-2024-00004
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K212379
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473175B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male