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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states customer contacted a siemens customer care center (ccc) and reported that erroneous enzymatic hemoglobin a1c (a1c_e) results were obtained on multiple 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 hemoglobin a1c (a1c_e) results obtained on sixty-three (63) patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were reprocessed on an alternate atellica ch 930 analyzer.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous a1c 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: 23956024
• Report Number: 2432235-2026-00002
• Device Sequence Number: 17577402
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150365(17)260804
• 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,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: 08/04/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 06/10/2026
• Date Device Manufactured: 08/22/2025
• 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