MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 15-3; SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer identified discordant (depressed) atellica im ca15-3, lot 218, patient sample results.The discordance was found after an issue with quality control (qc) results was resolved and patient samples were retested were subsequently retested on a different atellica im analyzer.The initial depressed patient results were reported, but not questioned by physician(s).Corrected reports were issued for the samples using the higher retest results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).Siemens competed the investigation for an ous customer observation of imprecise quality control (qc) and discordant patient results with atellica im ca15-3 lot 218, on 1 of 2 instruments in their laboratory.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens customer service engineer (cse) was onsite and did note observe any issues with the reagent pack on the instrument in question.The other instrument was performing as expected with same reagent lot and calibrator lot.Siemens cse reviewed the system event log.It was found that atellica im ca15-3 lot 218 reagent pack was scanned approximately 3 am on (b)(6) 2024 and irregular aspiration errors for ca15-3 calibration occurred around 9 am.The cse replaced the sample plunger and tubing and observed debris in the sample plunger.No issues were found with the sample probe and tip tray alignments.Qc was run after service and all results were within specifications.Acceptable qc has occurred consistently since instrument service.The customer is operational, and the reported issue is resolved by routine troubleshooting.

• Brand Name: ATELLICA IM CA 15-3
• Common Device Name: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• 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
• MDR Report Key: 20539857
• Report Number: 1219913-2024-00453
• Device Sequence Number: 12432769
• Product Code: MOI
• UDI-Device Identifier: 00630414598123
• UDI-Public: (01)00630414598123(10)82016218(17)250507
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192777
• 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): 10/26/2024

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: 05/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995485
• Device Lot Number: 82016218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 05/07/2024
• 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 Sex: Unknown