MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9 ASSAY; SYSTEM, TEST, CA19-9, FOR MONITORING AND 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	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The united states customer reports observation of a discordant depressed result for one patient sample when running ca 19-9 lot 522 on atellica im 1600 analyzer.The sample was repeated multiple times with dilution on another atellica im 1600 analyzer and higher results were obtained.The interpretation of results section of the advia centaur ca 19-9 instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the customer reported the initial issue as a sample that when tested without dilution recovered 492 u/ml with ca 19-9 kit lot 522 on atellica im im00453 but when diluted 1/10 and 1/100 the sample recovered 2,000 u/ml with the same reagent pack.When the sample was initially run a sample integrity error prevented a result from being generated.When tested on a different analyzer (atellica im im00449) with ca 19-9 kit lot 522 the sample recovered > 700 u/ml without dilution and 2,000 u/ml when diluted.(b)(6) investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges, the same reagent pack generating accurate diluted results, and no issues were reported with other patient samples.Assessment of instrument performance included a review of auto check data, traces files, and logs.Based on the review there is no evidence the nonrepeatable depressed result was caused by the analyzer.Based on the available information, the cause of the discordant result could not be determined but siemens cannot rule out preanalytical variables or sample integrity.Return of the patient sample for further investigation is not warranted because the discordant result was not reproducible.The customer is operational.
Event or Problem Description
The customer reports observation of a discordant depressed result for one patient sample when running ca 19-9 lot 522 on atellica im 1600 analyzer.The initial result was reported to the physician(s), who did not question the result.The sample was repeated multiple times with dilution on another atellica im 1600 analyzer and higher results were obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant, ca 19.9 results.

• Brand Name: ATELLICA IM CA 19-9 ASSAY
• Common Device Name: SYSTEM, TEST, CA19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17798369
• Report Number: 1219913-2023-00216
• Device Sequence Number: 12662869
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: 00630414598178
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K031393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2023

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: 11/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995490
• Device Lot Number: 522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/22/2023
• Date Device Manufactured: 01/03/2023
• 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: 67 YR
• Patient Sex: Male