MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9 ASSAY; SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING 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	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer reported observation of a discordant (high/475.63 u/ml) ca 19-9 result of an esophageal cancer patient sample on atellica im 1600 instrument, lot 528 vs.An alternate method.The initial result was reported to the physician(s), who questioned the result.This same sample was retested on an alternate testing platform, and the result was lower.The alternate testing platform result was considered as the correct result by the physician(s).All quality controls (qc) with ca19-9 assay were within the normal ranges.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues and instrument performance were ruled out based on qc which was within acceptable ranges, the patient sample results were repeatable, and no issues were reported with other patient samples.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.The customer is operational.
Event or Problem Description
The customer reports observation of a discordant (high) ca 19-9 result of a male patient sample on atellica im 1600 instrument, lot 528 vs.An alternate method.The initial result was reported to the physician(s), who questioned the result.This same sample was retested on an alternate testing platform, and the result was lower.The alternate testing platform result was considered as the correct result by the physician(s).

• Brand Name: ATELLICA IM CA 19-9 ASSAY
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING OF PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• 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: 18629247
• Report Number: 1219913-2024-00015
• Device Sequence Number: 18073909
• 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
• Report Date (Section B): 02/02/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 02/02/2024
• 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: 69 YR
• Patient Sex: Male