MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM CA 19-9 (CA 19-9); SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR 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	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur ca 19-9 result which was discordant relative to repeat testing using a different reagent lot.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, investigation did not confirm the complaint allegations of commercial 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 will be distributed to customers who have received the affected product to notify them of the bias.The communication will advise customers to discontinue use of the affected product.The customer has received this notice, and has ceased use of the affected product lot.
Event or Problem Description
The customer reports observation of an elevated atellica im ca 19-9 (ca 19-9) result from lot 535 which was discordant relative to repeat testing with lot 537.The customer received siemens field action notification aimc 24-14.A.Ous, informing of result bias associated with atellica im ca 19-9 lots ending in 535.As a result, they re-tested stored samples for which ca 19-9 results had been previously reported from lot 535.For one sample, they identified discordance between initial and repeat results, where the initial result was >3x higher than the repeat.The result report was corrected for this patient.There are no allegations of any adverse patient consequences in association with the discordant result.The customer has ceased using ca 19-9 lot 535, in accordance with the field-action notification.

• Brand Name: ATELLICA IM CA 19-9 (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: 19996694
• Report Number: 1219913-2024-00384
• Device Sequence Number: 7164398
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: (01)00630414598161(10)55977535(17)240914
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 08/16/2024

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: 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: 08/14/2024
• Initial Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 11/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: 27 YR
• Patient Sex: Male