MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated enzymatic hemoglobin a1c (a1c_e) results obtained on multiple patient samples on an atellica ch 930 analyzer.Calibration was acceptable.Quality control (qc) recovered acceptably before the event and recovered outside the range after the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit the cse inspected the analyzer, reviewed auto checks and found that reagent arm 1 was failing the alignment check, performed manual alignment for reagent arm 1 and ran auto alignment for both reagent servers, all three mixers and all four transfer arms.Then, the cse ran full auto check which passed, ran the atellica test protocol (atp) service methods which passed.Siemens is evaluating the event.
Event or Problem Description
The customer reported that they obtained erroneously elevated enzymatic hemoglobin a1c (a1c_e) results on multiple patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s) and were questioned.The samples were repeated on an alternate atellica ch 930 analyzer.The repeat results recovered lower and were consistent with the patient¿s clinical history.The corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated a1c_e results.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• 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: 24527901
• Report Number: 2432235-2026-00069
• Device Sequence Number: 8504439
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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 Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• 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