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

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported erroneous n terminal pro-brain natriuretic peptide (nt probnp), total human chorionic gonadotropin total hcg (thcg) and intact parathyroid hormone (pth) results were obtained on patient samples on an atellica im 1600 analyzer.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate atellica im analyzer.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the nt probnp, pth and tccg patient results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report erroneous n terminal pro-brain natriuretic peptide (nt probnp), total human chorionic gonadotropin total hcg (thcg) and intact parathyroid hormone (pth) results were obtained on patient samples on an atellica im 1600 analyzer.Quality controls (qcs) recovered out of ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse checked the tubing from the aspirate probe down to the waste reservoir and found a small occlusion in the fitting but between aspiration probe tubing and pinch valve tubing.The cse replaced the tubing and the vacuum regulator.The cse performed an autocheck and the customer ran qcs which were found to be acceptable.Siemens further evaluated the event and concluded the probable cause of the erroneous nt probnp, thcg and pth results was due to a possible occlusion in the vacuum system.The instrument is performing according to specifications.No further evaluation of this device 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; tarrytown 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: 24823710
• Report Number: 2432235-2026-00091
• Device Sequence Number: 9594547
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/09/2026

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: 03/31/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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