MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CA 19-9; SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR 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	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed advia centaur ca 19-9 result which was discordant relative to clinical expectation and repeat testing.Assay calibration and quality control (qc) results were valid and within expected ranges.Local investigation by a siemens service engineer did not identify any instrument issues to explain the discordant result.Siemens is investigating.
Event or Problem Description
The customer reports observation of a depressed advia centaur ca 19-9 result which was discordant relative to clinical expectation and repeat testing.Ca 19-9 lot 530 was in use at the time.A low ca 19-9 result (within normal range) was obtained for a 62-year-old female patient with pneumonia.Assay calibration and quality control (qc) results were valid and within expected ranges.The result was questioned by the physician, and a new sample was drawn and tested using a different reagent lot two days later.The new sample produced a much higher result, which was reproduced in duplicate testing.The earlier sample was re-tested as well, and it also produced a much higher result than first obtained.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00298 was initially submitted on 01-apr-2024.A customer from outside the united states reported observation of a depressed advia centaur ca 19-9 result when using lot 530 which was discordant relative to repeat testing using another reagent lot.Siemens has concluded the investigation.The advia centaur xpt instrument was inspected, and no issues were identified.There is no additional sample material available for investigation.The initial elevated result was discordant relative to testing of both a new sample and the original sample using a different reagent lot (535).It was noted that results for bio-rad quality control level 1 shifted downward when the customer switched to ca 19-9 lot 535, although they were still within published ranges.This qc bias is consistent with other observations for this lot, and does not explain the observed difference seen for this patient, where the initial result from lot 530 was identified as falsely depressed relative to lot 535.A specific cause for the discordant observation could not be determined on the basis of the available information.However, no product problem was identified.The customer is operational, and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR CA 19-9
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR 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.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19220196
• Report Number: 1219913-2024-00298
• Device Sequence Number: 8105562
• Product Code: NIG
• UDI-Device Identifier: 00630414574257
• UDI-Public: 00630414574257
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 05/23/2024

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: 04/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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: 62 YR
• Patient Sex: Female