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 Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that a discordant, falsely low free light chain (flc) kappa serum result was obtained on a patient sample on a bn ii system using n latex flc kappa reagent.Siemens investigated the issue.Quality controls (qc) recovered within range at the time of the event.The discordant result was limited to the flc kappa determination for only one patient sample.As per the instructions for use (ifu) for n latex flc kappa / n latex flc lambda, "patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.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." the cause of the falsely depressed flc kappa serum result 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 chain (flc) kappa serum result was obtained on a patient sample that was run in a 1:100 dilution on a bn ii system using n latex flc kappa reagent.The discordant result was not reported to the physician(s).The same sample was repeated for flc kappa five times on the same system with the same reagent using five different dilutions (1:20, 1:100, 1:400, 1:2000, and 1:8000).The four lower dilutions recovered higher than the initial 1:100 dilution but lower than the 1:8000 dilution.The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low flc kappa serum 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 10710 ; 9145242740
• MDR Report Key: 9202832
• MDR Text Key: 175417940
• Report Number: 9610806-2019-00076
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• 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: 68 YR