MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer reported a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1600 analyzer.Quality controls (qcs) recovered within ranges on the day of the event and then when qc was run upon suspicion of an issue and the qc recovered out of ranges.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the system and found a partially clogged aspiration probe 1.The cse unclogged the aspiration probe 1 connector.Siemens is evaluating the event.
Event or Problem Description
The customer reported a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an atellica im 1600 analyzer.The erroneous result was not reported to the physician(s).The sample was repeated on an alternate atellica im analyzer.The repeat result was lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated thcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00078 on 17-mar-2026.Additional information: (11-may-2026): siemens performed a review of the autocheck data which indicated that the vacuum system required troubleshooting.Siemens further evaluated the event and concluded that the potential cause of the falsely elevated total human chorionic gonadotropin (thcg) result was a clogged aspirate probe.The investigation conclusion code in section h6 was updated to reflect the additional information.No further investigation into this analyzer is required.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarryown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 24620323
• Report Number: 2432235-2026-00078
• Device Sequence Number: 18538195
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 06/03/2026

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 1600 ANALYZER
• Device Catalogue Number: 11066000
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown