MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM FOLATE (FOL); FOLATE ASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) to report an elevated atellica im folate (fol) result that was considered discordant with the repeat result.The customer processed the serum sample using the folate rbc assay instead of the folate serum assay on the atellica im 1300 analyzer.The quality controls (qc) were in range at the time of the event.A siemens technical application specialist (tas) went to the customer's site.During the visit, the tas assisted the customer in deactivating fol (fol rbc) assay and adding the fol serum assay.The reagents were calibrated, and qc was run successfully.The sample was repeated, and the repeat result was reported to the physician(s), as the correct result.The interpretation of results section of the atellica im folate (fol) instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer obtained an elevated atellica im folate (fol) result that was considered discordant with the repeat result.The initial result was reported to the physician(s) and was not questioned.There are no known reports of patient intervention or adverse health consequences due to the discordant folate result.

Manufacturer Narrative

Mdr 1219913-2022-00365 was filed on 2022-10-28 reporting an elevated result compared to repeat testing.A united states (us) customer contacted a siemens customer care center (ccc) to report an elevated atellica im folate (fol) result that was considered discordant with the repeat result.Additional information: 2023-01-09.Siemens reviewed the information and determined that factors such as pre-analytical factors and/or a sample handling/ stability issue cannot be ruled out as the cause of the elevated result.Internal siemens investigation indicates that the instrument and reagents were performing acceptably.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM FOLATE (FOL)
• Type of Device: FOLATE ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avemue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 7372808688
• MDR Report Key: 15690551
• MDR Text Key: 306827007
• Report Number: 1219913-2022-00365
• Device Sequence Number: 1
• Product Code: CGN
• UDI-Device Identifier: 00630414598963
• UDI-Public: 00630414598963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995572
• Device Lot Number: 337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1