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 09/19/2022

Event Type  malfunction  

Event Description

A discordant, falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample using a 1:100 sample dilution on an atellica neph 630 system using n latex flc kappa reagent.The discordant result was not reported to the physician(s).The following day, the same sample was repeated for flc kappa using a 1:100 sample dilution with the same system and reagent, recovering falsely low.The discordant result was not reported to the physician(s).Three days later, the sample was repeated three times for flc kappa, two times using a 1:100 sample dilution and one time using a 1:400 sample dilution, with the same system and reagent.The result obtained with the 1:400 sample dilution recovered higher and the results obtained with the 1:100 sample dilution recovered falsely low.The higher result matched with the patient's electrophoresis result and was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant flc kappa results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.Siemens is investigating the issue.Mdrs 9610806-2022-00049 and 9610806-2022-00050 were filed for the discordant results obtained on (b)(6) 2022 and (b)(6) 2022, respectively.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2022-00051 on 14-oct-2022.Additional information (20-oct-2022): quality controls (qc) recovered in range at the time of the event.As per the instruction 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 fit to previous ones, or to results of other tests (e.G.Serum immunoelectrophoresis, immunofixation, differential blood cell count) and/or to the clinical situation, it is recommended to re-analyze the sample in a higher sample dilution." based on the provided information, no analytical test was performed with the complained sample to determine the concentrations of monoclonal immunoglobins.Therefore, the effect of potentially elevated monoclonal immunoglobin concentrations cannot be ruled out as a potential cause of the event.No assay related potential product problem was identified.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Supplemental mdrs 9610806-2022-00049 and 9610806-2022-00050 were also filed for the additional information obtained on 20-oct-2022.

• 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; siemens healthcare diagnostics; 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: 15607471
• MDR Text Key: 307108737
• Report Number: 9610806-2022-00051
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473165A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• 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: 73 YR
• Patient Sex: Male