MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA19-9 (CA 19-9); SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PA

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer identified discordant atellica im atellica im ca19-9 (ca 19-9) patient results after a quality control (qc) issue occurred.After the qc issue was identified, patient samples previously tested were retested on a different atellica im instrument and the discordance between results was identified.The complaint indicates that the initial results were reported but not questioned by physicians and the retest results were reported as correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca 19-9 results.The customer replaced the reagent pack and calibrated the assay.The customer ran quality control (qc), which recovered in range.Siemens is investigating.
Event or Problem Description
The customer identified discordant atellica im atellica im ca19-9 (ca 19-9) patient results after a quality control (qc) issue occurred.After the qc issue was identified, patient samples previously tested were retested on a different atellica im instrument and the discordance was identified.The complaint indicates that the initial results were reported but not questioned by physicians and the retest results were reported as correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca 19-9 results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00499 initial report on 12-dec-2024.Siemens completed the investigation for a customer report of atellica im cancer antigen 19-9 (ca 19-9) lot 541discordant patient results on atellica im sn# (b)(6) vs.Repeat testing that was conducted due to out-of-range quality control (qc) results.The samples were repeated on an alternate atellica im analyzer (sn# (b)(6).Siemens evaluated customer data (calibration and qc) and evaluated system files.Based on the evaluation, siemens customer service engineer (cse) was dispatched to the account to perform routine vacuum and fluidics troubleshooting, as well, as acid dispense.A reagent issue was ruled out as the source of the problem.Siemens evaluated the precision performance of ca 19-9 lot 541 after conclusion of service actions (atellica im sn# (b)(6); precision performance was within expected ranges.Meanwhile, the customer calibrated ca 19-9 lot 545 and it is satisfied with the performance of the assay.Customer declined further troubleshooting and siemens support.Based on the information provided the cause of the nonrepeatable elevated results could not be determined.The customer is operational.

• Brand Name: ATELLICA IM CA19-9 (CA 19-9)
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20915110
• Report Number: 1219913-2024-00499
• Device Sequence Number: 7846542
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: (01)00630414598178(10)10595541(17)250424
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K031393
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 04/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995490
• Device Lot Number: 10595541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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