MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM FOLATE ASSAY

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 11/29/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 307928943
• Report Number: 1219913-2022-00452
• Device Sequence Number: 1
• Product Code: CGN
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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