MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 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	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The united states customer obtained discordant elevated atellica im folate results for two patients.The initial results were reported to the physician(s), who did not question the results.  the same samples were repeated using folserum on the same atellica im analyzer, and the results were low.The interpretation of results section of the atellica im folate 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 continues to investigate.
Event or Problem Description
The customer obtained discordant elevated atellica im folate results for two patients.The initial results were reported to the physician(s), who did not question the results.  the same samples were repeated using folserum on the same atellica im analyzer, and the results were low.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant folate results.
Additional Manufacturer Narrative
Initial mdr 1219913-2022-00452 was filed on 2022-dec-20 reporting an elevated result compared to repeat testing.Additional information on 2023-jan-09: 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 ASSAY
• 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: 16015775
• Report Number: 1219913-2022-00452
• Device Sequence Number: 17977137
• Product Code: CGN
• UDI-Device Identifier: 00630414598963
• UDI-Public: 00630414598963
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/25/2023

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: 05/29/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995572
• Device Lot Number: 339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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