MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	11066000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer observed a difference in the alpha fetoprotein (afp) test results from an atellica im 1600 analyzer (s/n (b)(6)) versus an alternate atellica im 1600 analyzer.A siemens regional support specialist (rsc) investigated the reported issue.The rsc found that the afp conversion factor was set to 1.2 when it should have been set to 0.83.The test results would be approximately 44% lower (conversion factors 1.2/0.83 times test result) if the correct conversion factor was entered initially.The default unit of measure for afp is ng/ml.The alternate unit of measure is iu/ml.The customer is reporting test results in the unit ku/l which is equivalent to iu/ml.The correct conversion factor from the default unit of measure to the customer¿s preferred unit of measure is ng/ml x 0.83 = ku/l.The customer¿s preferred unit of measure is not supported by the siemens test definition and the customer would have to manually enter the correct conversion factor.The cause of the reported issue is an incorrect manual entry of the conversion factor.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
An outside of the united states (ous) customer observed a difference in the alpha fetoprotein (afp) test results from an atellica im 1600 analyzer (s/n (b)(6)) versus an alternate atellica im 1600 analyzer.Afp test results from s/n (b)(6) were approximately 44% higher than expected.The initial test results were released to a physician.It is unknown if the original samples were repeated and corrected test result reports released.The customer indicated that the afp test is being used for cancer screening purposes only.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The initial mdr 2432235-2026-00033 was filed 06-feb-2026.Additional information (06-feb-2026): added related report numbers.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co; tarrytown ; EI
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 24280357
• Report Number: 2432235-2026-00033
• Device Sequence Number: 20912618
• 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,Followup
• Report Date (Section B): 02/09/2026

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 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown