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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Mdr 1219913-2022-00371 was filed on oct 31, 2022 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: jan 09, 2023.Siemens reviewed the information and determined that the elevated result is not attributable to the use of the incorrect fol calibration for serum samples because internal testing shows that use of the incorrect calibration yields lower values rather than higher values.Contributing factors such as pre-analytical factors and/or a sample handling/ stability issue cannot be ruled out.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)
• Common Device Name: FOLATE ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 15699338
• Report Number: 1219913-2022-00371
• Device Sequence Number: 8246027
• Product Code: CGN
• UDI-Device Identifier: 00630414598963
• UDI-Public: 00630414598963
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown