MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CREATININE_2 (CREA_2)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously depressed creatinine_2 (crea_2) results were obtained on nine patient samples on an atellica ch 930 analyzer.The erroneous results were not reported to the physician(s).The samples were reprocessed either on the original analyzer or on an alternate atellica ch 930 analyzer.The reprocessed results were higher than the erroneous results and matched the patient¿s clinical picture.The reprocessed results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed creatinine_2 (crea_2) results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed creatinine_2 (crea_2) results were obtained on nine patient samples on an atellica ch 930 analyzer.Calibration was acceptable, and quality control (qc) was within the range on the day of the event.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00300 on 28-nov-2025.Additional information (10-dec-2025): siemens reviewed the instrument data files, and the information provided by the customer.Siemens review indicated that the customer was running patient samples without any issues on reagent well 1, but erroneous results were obtained when samples were processed on reagent well 2.Quality control (qc) was out of range when well 2 was used, but within range when well 1 was used.There were no sample aspiration or hardware issues during the use of well 2.Siemens determined that a compromised reagent well of unknown cause potentially contributed to the erroneously depressed creatinine_2 (crea_2) results.A product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CREATININE_2 (CREA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin, co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23670401
• Report Number: 2432235-2025-00300
• Device Sequence Number: 9708170
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)252520(17)260901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161494
• 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): 12/26/2025

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: 09/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 252520
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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