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

Model Number N LATEX FLC KAPPA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/20/2021

Event Type  malfunction  

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.Mdr 9610806-2022-00001 was filed for the flc kappa result obtained on (b)(6) 2021.

Event Description

A high 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.Two days later, the same sample was repeated for flc kappa, recovering lower.It is unknown which result was considered to be the correct result, and it is unknown if the initial or repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant flc kappa result(s).

Manufacturer Narrative

Siemens filed the initial mdr on 06-jan-2022.Additional information (18-jan-2022): quality controls (qc) recovered in range at the time of the event.The issue was limited to one patient sample.Based on the information provided, the cause of the event could not be determined.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Supplemental mdr 9610806-2022-00001_s1 was also filed for the additional information obtained on 18-jan-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; 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: 13178861
• MDR Text Key: 285548918
• Report Number: 9610806-2022-00002
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: N LATEX FLC KAPPA
• Device Catalogue Number: 10482437
• Device Lot Number: 473161B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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