MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA); CEA IMMUNOASSAY

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	12/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer calibration and qc were within specification.The interpretation of results section of the assay 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
A customer obtained an initial discordant high atellica im carcinoembryonic antigen (cea) patient sample result.The discordant result was not reported to the physician.Per customer protocol, the sample was sent to another testing site (pls aa1).The same sample was also repeated at the customer site (pls meh) 2 days later.Both repeat results were lower than the initial discordant result.The repeat result was reported to the physician as the correct result.There are no known reports of patient intervention or adverse health consequences due to the initial discordant cea result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics filed mdr 1219913-2021-00014 initial report on 01/07/2021.Additional information - 02/10/2021: siemens has completed investigation for one non-reproducible elevated atellica im carcinoembryonic antigen (cea) patient sample result.A siemens atellica im hardware specialist reviewed the instrument logs.The sample probe and reagent probe traces did not show any defects for cea.Potential issues that can cause an increased result with atellica im cea is wash aspiration issues, base delivery or system contamination.There was no indication in the system logs of either of these potential issues.Customer sample handling was reviewed.The sample was initially tested on (b)(6) 2020 (discordant result) and was re-spun before being repeated on (b)(6) 2020.The sample was also sent to another laboratory for testing and resulted similarly to result obtained on (b)(6) 2020 (lower results).Pre-analytic variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results.While there is insufficient information to determine the cause of the non-reproducible discordant result, siemens cannot rule out pre-analytical factors or a sample specific issue.Based on the information provided, no product non-conformance has been identified.Customer is operational.No further action is required.In section h6 of this report, the investigation findings and conclusion codes were updated to reflect the investigation results.

• Brand Name: ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)
• Common Device Name: CEA IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11133867
• Report Number: 1219913-2021-00014
• Device Sequence Number: 19836239
• Product Code: DHX
• UDI-Device Identifier: 00630414598505
• UDI-Public: 00630414598505
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K981478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 08/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995523
• Device Lot Number: 198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1