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

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	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) regarding erroneously elevated enzymatic hemoglobin a1c (a1c_e) results obtained on ten (10) patient samples on an atellica ch 930 analyzer.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.
Event or Problem Description
The customer reported to siemens they obtained erroneously elevated enzymatic hemoglobin a1c (a1c_e) results obtained on ten (10) patient samples on an atellica ch 930 analyzer.The erroneously elevated results were reported to the physician and not questioned.The same samples were reprocessed on an alternate atellica ch 930 analyzer.Lower results were obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated enzymatic hemoglobin a1c (a1c_e) results.

• Brand Name: ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
• Common Device Name: HEMOGLOBIN A1C TEST SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• 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: 25457763
• Report Number: 2432235-2026-00125
• Device Sequence Number: 16037329
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150232(17)260512
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• 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): Initial
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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