MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER

Model Number	ATELLICA IM 1300 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer informed siemens that a falsely elevated nt-probnp (pbnpii) patient result was obtained on the atellica im 1300 analyzer and reported to the physicians.The customer used an alternate atellica im analyzer to perform repeat testing and stated that the repeat result was considered correct.A corrected report was issued by the customer.There are no known reports of patient intervention or adverse health consequences associated with this event.
Additional Manufacturer Narrative
The customer informed siemens that a falsely elevated nt-probnp (pbnpii) patient result was obtained on the atellica im 1300 analyzer.The customer requested assistance and reported that the sample was re-run on an alternate atellica im analyzer at the same laboratory.Siemens dispatched a customer service engineer to the customer site.The customer service engineer performed troubleshooting, identified a clogged wash probe, completed corrective service actions, and verified that the analyzer was operating as specified.Siemens healthineers reviewed the service activities and determined that the atellica im 1300 analyzer stopped as a result of a wash station dispense check failure.The customer service engineer investigated the failure and identified that the analyzer failed the auto check for wash aspirate probe 1 due to a vacuum error caused by clogged tubing.The customer service engineer replaced the wash aspirate probe 1 tubing, which removes unbound material in the wash ring, and restored the analyzer to normal operation.The potential cause of the falsely elevated nt-probnp (pbnpii) patient result was attributed to the clogged wash aspirate probe 1 tubing.The analyzer is functioning as specified, and no further evaluation is required.

• Brand Name: ATELLICA IM 1300 ANALYZER
• Common Device Name: ATELLICA IM 1300 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane; registration number: 8020888; swords, co. dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 25518111
• Report Number: 2432235-2026-00137
• Device Sequence Number: 13246850
• Product Code: JJE
• UDI-Device Identifier: 00630414007960
• UDI-Public: (01)00630414007960
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K151792
• 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): 06/16/2026

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 Model Number: ATELLICA IM 1300 ANALYZER
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Unknown