MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed enzymatic hemoglobin a1c (a1c_e) result obtained on a patient sample on an atellica ci 1900 analyzer.Calibration and quality control (qc) were acceptable on the day of the event.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they observed an erroneously depressed enzymatic hemoglobin a1c (a1c_e) result obtained on a patient sample on an atellica ci 1900 analyzer.The erroneous result was reported to the physician(s), and the result was not questioned.The sample was reprocessed on the original analyzer.Additionally, a new sample was drawn from the same patient and processed on the original analyzer.Both the reprocessed and redrawn sample results were higher than the erroneous result and matched the patient¿s clinical history.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed enzymatic hemoglobin a1c (a1c_e) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00288 on 11-nov-2025.Additional information (17-nov-2025): siemens reviewed the information provided by the customer, and the available instrument data files.Siemens' review of the instrument data indicated there was no instrument or assay problem occurring which caused the apparent erroneously depressed enzymatic hemoglobin a1c (a1c_e) result.Siemens evaluated the event and determined that the probable cause of the behavior is the customer¿s lack of understanding of the a1c_e assay and interpretation of the flags it may generate.Siemens enhanced customer understanding by providing relevant information.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23520184
• Report Number: 2432235-2025-00288
• Device Sequence Number: 13187943
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150045(17)260203
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K200256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 02/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150045
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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 Sex: Unknown