MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CA 19-9; CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING/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	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of elevated advia centaur ca 19-9 lot 535 patient sample results which were discordant relative to alternate-method testing (atellica im ca 19-9 lot 533).For the patient samples in question, the initial advia centaur ca 19-9 results were above the expected value range (>37 u/ml).These initial results were not reported to physician(s).When the same samples were re-tested using an alternate method ( atellica im ca 19-9 lot 533), the results were lower, which were reported to physician(s) as correct.Re are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
The customer reports observation of elevated advia centaur ca 19-9 lot 535 patient sample results which were discordant relative to alternate-method testing (atellica im ca 19-9 lot 533).For the patient samples in question, the initial advia centaur ca 19-9 results were above the expected value range (>37 u/ml).These initial results were not reported to physician(s).When the same samples were re-tested using an alternate method ( atellica im ca 19-9 lot 533), the results were lower, which were reported to physician(s) as correct.Siemens is investigating.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00328 initial report on 24-may-2024.Siemens investigation confirmed an average positive bias of 56.4% with a sample population from the asia pacific region and atellica im and advia centaur 19-9 assay kit lots ending in 535 as compared to previous lots.However, the investigation did not confirm quality control results outside of range.Urgent medical device correction (umdc) aimc 24-14.A.Us and urgent field safety notice (ufsn) aimc 24-14.A.Ous were distributed to customers who have received the affected product to notify them of the bias.The communication advised customers to discontinue use of the affected product.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR 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: 19389223
• Report Number: 1219913-2024-00328
• Device Sequence Number: 12698727
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: 00630414598161
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 09/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1219913-07-18-2024-002-C
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female