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

Model Number N LATEX FLC KAPPA

Device Problem High Test Results (2457)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer indicated that the issue was resolved after using a new reagent vial.Siemens requested the bn ii system troubleshooting files on 3 separate dates, but the customer did not provide the troubleshooting files.Based on the information provided, calibration and quality control (qc) performance did not indicate any assay or system related issue.Further evaluation is not possible based on the information provided.The system 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.

Event Description

A falsely elevated free light chains, type kappa (flc kappa) result was obtained on a patient sample 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 two times on the same system, both times recovering lower.The lower results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated flc kappa result.

• 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: 18133134
• MDR Text Key: 328129328
• Report Number: 9610806-2023-00020
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 473174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male