MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH ACETAMINOPHEN; COLORIMETRY, ACETAMINOPHEN

Model Number	ATELLICA CH ACETAMINOPHEN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer made a mistake when calibrating the assay.The calibrator values were entered as mg/dl (default units) but the assay was configured as mg/l.The customer recalibrated the assay with the correct units, which resolved the issue.No reagent nor instrument issues were identified.No further evaluation is required.The customer is operational.The device is performing within specifications.A potential product issue was not identified.The cause of the event is user error.
Event or Problem Description
The customer reported to siemens that three erroneously depressed acetaminophen (acet) results were obtained on an atellica ch 930 analyzer.The erroneously depressed patient results were reported to the physician and were not questioned.The same samples were reprocessed on the same atellica ch 930 analyzer.Higher results were obtained, considered correct and reported to the physician.

• Brand Name: ATELLICA CH ACETAMINOPHEN
• Common Device Name: COLORIMETRY, ACETAMINOPHEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC.; registration # 8020316; 70 watts avenue; charlottetown, pe C1E 2 B9; CA C1E 2B9
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 25023752
• Report Number: 2432235-2026-00098
• Device Sequence Number: 8919778
• Product Code: LDP
• UDI-Device Identifier: 00630414595894
• UDI-Public: 00630414595894
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100200
• 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): 04/29/2026

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 Expiration Date: 05/29/2026
• Device Model Number: ATELLICA CH ACETAMINOPHEN
• Device Catalogue Number: 11097522
• Device Lot Number: 150253
• 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: 04/20/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male