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

Model Number N LATEX FLC KAPPA

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that different flc kappa results were obtained on a patient sample on a bn prospec system using n latex flc kappa reagent (lot number: 473145) when running the sample in different dilutions.Siemens investigated the issue and determined that the kinetic curves fit the observed result values.Quality control results were within specifications.A potential cause for the result discrepancies for this one single patient sample in the different sample dilutions is that high concentrations of bound-light chains may influence flc kappa results.As per the instructions for use (ifu) for n latex flc kappa, "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 match previous results, it is recommended to re-analyze the sample in a higher sample dilution.The cause of the event is unknown and is limited to this single patient sample.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that different flc kappa results were obtained on a patient sample on a bn prospec system using n latex flc kappa reagent (lot number: 473145) when running the sample in different dilutions.It is unknown if any of these results were reported to the physician(s).The correct results for this patient are unknown.There are no known reports of patient intervention or adverse health consequences due to the different flc kappa results.

• 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 ; 9145242740
• MDR Report Key: 8768332
• MDR Text Key: 150292146
• Report Number: 9610806-2019-00060
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• 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: 69 YR