MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM BR 27.29 (BR); SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer reported observation of elevated atellica im br 27.29 (br) results which were discordant relative to repeat testing.No issues were identified with assay calibration or quality control (qc) results.Siemens is investigating.
Event or Problem Description
The customer reports observation of elevated atellica im br 27.29 (br) results which were discordant relative to repeat testing when using br lot 272.The customer tested 69 atellica im br samples on (b)(6)2025, and the results were questioned by physicians.The results were generally identified as falsely elevated.10 samples with sufficient remaining volume were re-tested on another atellica im analyzer.Results were lower upon repeat testing; 7 of these samples demonstrated differences between initial and repeat tests of 30% or greater.There are no allegations of any adverse patient consequences due to the observed result discordance.
Additional Manufacturer Narrative
A united states customer reported observation of elevated atellica im br 27.29 (br) results which were discordant relative to repeat testing.Mdr 1219913-2025-00042 was initially submitted on 25-feb-2025.Update, 08-apr-2025: siemens has concluded the investigation.Review of customer data showed that the customer performed three reagent-pack calibrations on the day of the event.All three calibrations demonstrated higher signal levels than seen in previous calibrations for the same reagent lot.These calibrations met defined-range specifications, but exceeded observed ranges, and therefore required operator review and acceptance; calibration was operator-accepted for the results in question.It was also noted that the quality control (qc) results associated with these calibrations were generally high, and above range for levels 1 and 2.Siemens assisted with on-site troubleshooting.The br assay was recalibrated, and observed signal levels returned to expected ranges.Acceptable qc results were produced following recalibration.Siemens master curve material (mcm) was tested, and produced results within expected ranges; precision was verified.The customer is operational, and the reported issue was resolved by recalibration, which is considered routine troubleshooting.There is no indication of any reagent or instrument issues, and no systemic product problems were identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM BR 27.29 (BR)
• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21460884
• Report Number: 1219913-2025-00042
• Device Sequence Number: 18088094
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: (01)00630414598055(10)09784272(17)250810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 08/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 09784272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: Female