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 10/05/2021

Event Type  malfunction  

Event Description

A discordant, falsely low free light chains, type kappa (flc kappa) result was obtained on a patient sample on an atellica neph 630 system using n latex flc kappa reagent using a 1:100 sample dilution.The discordant result was not reported to the physician(s).The sample was repeated for flc kappa using a 1:400 dilution, recovering higher than the initial result.The sample was then repeated for flc kappa using a 1:2000 dilution, recovering higher than the initial result.The sample was then repeated again for flc kappa using a 1:400 dilution, recovering higher than the initial result.The higher repeat results were considered to be the correct results.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc kappa result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality control (qc) data was not provided by the customer.No system or reagent abnormalities were identified.The issue was limited to one patient sample.The cause of the event 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 chains, type kappa (flc kappa) result was obtained on a patient sample on an atellica neph 630 system using n latex flc kappa reagent using a 1:100 sample dilution.The discordant result was not reported to the physician(s).The sample was repeated for flc kappa using a 1:400 dilution, recovering higher than the initial result.The sample was then repeated for flc kappa using a 1:2000 dilution, recovering higher than the initial result.The sample was then repeated again for flc kappa using a 1:400 dilution, recovering higher than the initial result.The higher repeat results were considered to be the correct results.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc kappa result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality control (qc) data was not provided by the customer.No system or reagent abnormalities were identified.The issue was limited to one patient sample.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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: 12802833
• MDR Text Key: 286078420
• Report Number: 9610806-2021-00069
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2021
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473159A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• 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