MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 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	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare remote services center (rsc) regarding repeat elevated results on one patient sample using atellica im ca 19-9 lot 528.The same sample was tested on an alternate method and result was lower, and considered correct.For troubleshooting purposes, the customer retested the original sample on the original instrument after peg (polyethylene glycol) treatment and a lower result of 3.16 u/ml was obtained.The quality control (qc) recovered within customer¿s laboratory ranges prior to patient sample testing.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." siemens is investigating.
Event or Problem Description
The customer obtained repeat elevated results on one patient sample using atellica im ca 19-9 lot 528.The elevated results were not reported to the physician.The same sample was tested on an alternate method and result was lower.This result was reported to the physician as the correct result.There are no known reports of patient intervention or adverse health consequences due to elevated ca 19-9 results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2023-00329 initial report with the fda on 15-dec-2023.Additional information ¿ 26-dec-2023.Siemens concluded the investigation for an outside of the united states (ous) customer observation of repeat elevated results on one patient sample using atellica im ca 19-9 lot 528 compared to lower retest results on an alternate test method.Siemens¿s investigation included an assessment of reagent, instrument, and sample data.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges, sample results were repeatable, and no issues were reported with other patient samples.The customer treated the sample with polyethylene glycol (peg) 6000 and it recovered significantly lower with the atellica im 1600 ca19-9 assay.Treatment of the sample with peg may have precipitated antibodies that were interfering with the atellica im 1600 ca19-9 assay.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.A product problem was not identified.The customer is operational.In section h6, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM 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.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18340134
• Report Number: 1219913-2023-00329
• Device Sequence Number: 6712198
• 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): 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): 01/19/2024

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: 03/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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: 68 YR
• Patient Sex: Female