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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated enzymatic hemoglobin a1c (a1c_e) results obtained on five patient samples on an atellica ch 930 analyzer.Quality control (qc) recovered out-of-range on the day of the event.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously elevated enzymatic hemoglobin a1c (a1c_e) results were obtained on five patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s), who did not question the results.The samples were reprocessed on the original analyzer.The reprocessed results were lower than the erroneous results and matched the patient¿s clinical picture.For sample identifier (b)(6), the sample was sent out for alternate methodology testing.The customer did not provide further information, and it is unknown whether the correct result was reported to the physician(s).For the other sample identifiers, the reprocessed 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 erroneously elevated enzymatic hemoglobin a1c (a1c_e) results.
Additional Manufacturer Narrative
Additional information (02-june 2026): siemens healthineers has confirmed the potential for intermittent well-to-well bias affecting the a1c_e/a1c_h assay when used on the atellica ch and atellica ci systems.Us customers were notified through an urgent medical device correction (umdc, letter achc26-06.A.Us) and ous customers were identified through urgent field safety notice (ufsn, letter achc26-06.A.Ous) titled ¿potential for well-to-well bias affecting atellica enzymatic hemoglobin a1c assay results¿.The communication was directed to all customers who received atellica ch enzymatic hemoglobin a1c (a1c_e) impacted lots informing them of the issue and providing instructions the customer must follow.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2432235-2025-00314 was filed on 11-dec-2025.

• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 23776227
• Report Number: 2432235-2025-00314
• Device Sequence Number: 10091784
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150232(17)260512
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 05/12/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150232
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-06/08/2026-003-C
• Patient Sequence Number: 1
• Patient Sex: Unknown