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	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) and reported that they obtained erroneously depressed creatinine 2 (crea 2) results on sixteen patient samples on an atellica ch 930 analyzer.Quality control (qc) was out of range on the affected well but recovered within the range on different well.Siemens is evaluating the event.
Event or Problem Description
The customer reported that they obtained erroneously depressed creatinine 2 (crea 2) results on sixteen 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 alternate atellica ch 930 analyzers.The repeat results matched the patient¿s clinical history and reported to the physician(s) as correct results.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00275 on 14-oct-2025.Additional information (07-nov-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer, and the available instrument data files.Quality control (qc) recovered low outside the customer's acceptable ranges, and erroneously depressed creatinine_2 (crea_2) patient-sample results were obtained when ran with a reagent lot calibration using well 2, and the qc recovered within the customer's acceptable ranges when ran with an alternate crea_2 lot using well 1.Siemens review did not identify any sample aspiration or hardware issues during the event.Siemens evaluated the event and determined that the compromised reagent well potentially contributed to the reported event.The cause of the compromised reagent well is unknown.A product issue was not identified.The device is performing according to the 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.; registration # 8020890; 55 diamond road,; 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: 23288377
• Report Number: 2432235-2025-00275
• Device Sequence Number: 8854706
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)252468(17)260501
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/01/2025

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: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 252468
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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