MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CA 19-9; SYSTEM, TEST, CA19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

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	06/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated advia centaur ca 19-9 results with lot 537 on four (4) patient samples which were discordant relative to repeat testing on an alternate method.Quality control (qc) recovered within customer established ranges.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is evaluating the event.
Event or Problem Description
The customer reports observation of elevated advia centaur ca 19-9 results with lot 537 which were discordant relative to repeat testing on an alternate method.Initial elevated results were obtained for four (4) patient samples.The initial results were not reported to the physician(s).The same samples were then retested using an alternate method and produced lower results.The lower results were considered correct as they agreed with the clinical condition of the patients and reported to the physician(s).It is unknown whether the affected patients have been diagnosed with cancer.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00350 was initially filed on 14-jun-2024.Additional information (25-jul-2024): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of elevated advia centaur ca 19-9 results with lot 537 on four (4) patient samples which were discordant relative to repeat testing on an alternate method.Siemens evaluated the instrument data and the information provided by the customer.The quality control (qc) was performing acceptably.Customer was unable to return patient samples to siemens for investigation due to local country regulations.The assay's instructions for use (ifu) stated the following under expected values section: 3.7% of samples from normal patients recovered >37 iu/ml so a certain number of elevated results from normal patients can be expected for this assay.Also, per the limitations section: the assay is not supposed to be used as a screening test or for diagnosis.Elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.The concentration of ca 19-9 in a given specimen determined with assays from different manufacturers.Based on the available information, a specific cause for the discordant results was unable to be determined.A product problem was not identified.The customer is operational and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR CA 19-9
• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19539208
• Report Number: 1219913-2024-00350
• Device Sequence Number: 8413054
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: 00630414574028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 09/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• 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 Sex: Unknown