MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. 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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneously elevated enzymatic hemoglobin a1c (a1c_e) result on one (1) patient sample obtained on an atellica ch 930 analyzer.Additionally, the customer performed repeat testing on 10 random patient samples (data not available), all of which showed consistent and expected results.Quality control (qc) performance was reviewed and found to be within acceptable limits.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens an erroneously elevated hemoglobin a1c (a1c_e) result obtained on one (1) patient sample on an atellica ch 930 analyzer.The erroneously elevated patient result was reported to the physician and questioned.The same sample, along with a redraw was reprocessed on the next day on an alternate atellica ch 930 analyzer.The same lower result was obtained for both repeats, 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) result.

• Brand Name: ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
• Common Device Name: HEMOGLOBIN A1C
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 23831855
• Report Number: 2432235-2025-00318
• Device Sequence Number: 8954527
• Product Code: PDJ
• 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): 12/17/2025

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: 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): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/17/2025
• 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