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

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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneously elevated enzymatic hemoglobin a1c (a1c_e) results obtained for two (2) patient samples on an atellica ch 930 analyzer.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported to siemens erroneously elevated enzymatic hemoglobin a1c (a1c_e) results on two (2) patient samples were obtained on an atellica ch 930 analyzer.The erroneously elevated results were not reported to the physician.The same samples were reprocessed on the original 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: ASSAY, GLYCOSYLATED HEMOGLOBIN
• 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: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 9173315804
• MDR Report Key: 24305096
• Report Number: 2432235-2026-00042
• Device Sequence Number: 9678979
• Product Code: LCP
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150453(17)260922
• 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
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 09/22/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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