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	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed creatinine_2 (crea_2) result obtained on a patient sample on an atellica ch 930 analyzer.Quality control (qc) results were within range when the erroneous result was obtained.The customer ran qc after erroneous result was obtained, which recovered outside (low) the laboratory-established reference ranges on the event date.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed creatinine_2 (crea_2) patient sample result on an atellica ch 930 analyzer.The initial erroneously depressed result was reported to the physician(s), and the result was questioned.The same sample was reprocessed on the original atellica ch 930 analyzer.The reprocessed result recovered higher, matched the result that was obtained when reprocessed on an alternate atellica ch 930 analyzer, and was reported as the correct result 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) result.
Additional Manufacturer Narrative
Mdr 2432235-2025-00178 was initially filed on 04-jul-2025.Additional information (17-jul-2025): siemens concluded the investigation of the event.Siemens reviewed the available instrument data files, and the information provided by the customer.The customer observed low quality control (qc) results when using crea_2 reagent lot 242376 well 0, while the qc results were acceptable with well 1 of the same lot.A lot calibration was performed, which produced low calibrator values, although the qc results remained within the expected range.The depressed patient results were associated with the affected reagent well.Siemens recommended that the customer perform a pack calibration instead of a lot calibration while addressing qc issues on a new well.Based on the information available, the issue was attributed to a compromised reagent well, though the exact cause of the initial low qc recovery could not be determined.The customer is operational, and the issue was resolved by recalibration and switching to a new reagent lot.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 avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road, crumlin; registration # 8020890; county 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: 22402251
• Report Number: 2432235-2025-00178
• Device Sequence Number: 8408056
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242376(17)260101
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 01/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 242376
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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