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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained discordant atellica im ca19-9 lot 535 results on samples from a 69-year-old female undergoing chemotherapy.The interpretation of results section of the assay instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." siemens is investigating.Note: this mdr report addresses the results from 01-aug-2024.The results from 30-jul-2024 are being addressed in a separate report.
Event or Problem Description
The customer obtained elevated atellica im ca19-9 lot 535 results on samples from a 69-year-old female undergoing chemotherapy.The doctor is contesting the atellica im ca19-9 lot 535 results.Samples from the patient were tested and resulted at the high limit of the analytical measuring range (ami) of the assay (1.20¿700 u/ml per assay instructions for use).Dilution testing was performed, and the results did not demonstrate the expected dilution recovery.The samples were sent to a non-customer laboratory for dilution testing with an alternate method.The dilution results between atellica im ca 19-9 and the alternate method were similar.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens concluded investigation for a customer complaint of discordance between the undiluted and diluted results of a patient sample tested with the atellica im ca 19-9 assay, lot 535.Siemens investigated ca 19-9 dilution-recovery performance across multiple reagent lots, which included both manual and auto 1:10 dilutions with medical decision pool (mdp) level 5, which is commutable to patient samples, high calibrator lots c941h, c943h and c945h and high dose patient samples.The observed performance met the atellica im design verification requirements, which allow a +/- 30% tolerance for auto-dilution recovery.Further investigation demonstrated that the ca 19-9 assay has met accuracy specifications for all internal control materials tested during lot-qualification testing of lots released within the past two years.It is noted that dilution-recovery performance is not consistent across all samples, and it is possible that some patient samples may exhibit dilution over-recovery with mucin/mucin-like assays such as ca 19-9.The product¿s instructions for use (ifu) states ¿sample dependent nonlinear dilutions can be observed.¿ [reference: wild d, ed.The immunoassay handbook.4th ed.Oxford, uk: elsevier science; 2013:842].Additionally, it is important to note that the atellica im ca19-9 ifu states that the assay is useful as an aid in monitoring the status of patients having confirmed pancreatic cancer who have levels of serum at some point exceeding the median concentration.The assay is not intended for screening purposes and should always be used in conjunction with all other clinical and laboratory data.The assay provides results from 1.20 ¿ 700 u/ml.Only samples with levels >700 u/ml should be diluted before re-testing.Based on the investigation, a product problem was not identified and no further investigation is required.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.Siemens filed initial mdr 1219913-2024-00398 on 27-aug-2024.This mdr 1219913-2024-00398 supplemental 1 is filed for results obtained 01-aug-2024.Mdr 1219913-2024-00397 supplemental was filed for results obtained 29-jul-2024.

• Brand Name: ATELLICA IM CA 19-9
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING,MANAGEMENT OF PANCREATIC CANCER
• 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: 20074720
• Report Number: 1219913-2024-00398
• Device Sequence Number: 3075510
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: 00630414598161
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/26/2025

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: 09/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 55977535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 11/14/2023
• 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 Age: 69 YR
• Patient Sex: Female