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	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated enzymatic hemoglobin a1c (a1c_e) result on one (1) patient sample obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported a historical erroneously elevated enzymatic hemoglobin a1c (a1c_e) result was obtained on one (1) patient sample on an atellica ch 930 analyzer.The erroneously elevated patient sample result was reported to the physician and questioned.The same sample was reprocessed on the same atellica ch 930 analyzer.A lower result was 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) result.
Additional Manufacturer Narrative
Additional information (04-feb-2026): siemens healthcare diagnostics headquarters service operations support (sos) concluded the investigation of the event.Sos reviewed the instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer's expected ranges.No reagent nor instrument issues were identified.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2026-00017 was filed on 29-jan-2026.

• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 24209923
• Report Number: 2432235-2026-00017
• Device Sequence Number: 12133568
• Product Code: PDJ
• UDI-Device Identifier: 00630414220505
• UDI-Public: (01)00630414220505(10)150260(17)260602
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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,Followup
• Report Date (Section B): 02/09/2026

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: 06/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097536
• Device Lot Number: 150260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 06/23/2025
• 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 Age: 44 YR
• Patient Sex: Unknown