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	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that erroneously depressed creatinine_2 (crea_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The erroneously depressed results were reported to the physician(s), who questioned the results.The same samples were reprocessed on an alternate atellica ch 930 analyzer.The reprocessed results were reported as correct results to the physician(s).Out of all the patients, new samples were drawn from the patients with sample identifiers (b)(6).The redrawn samples with sample identifiers (b)(6) were processed on the original analyzer.The redrawn sample with sample identifier (b)(6) was processed on an alternate atellica ch 930 analyzer.For sample identifier (b)(6), no correct crea_2 result was obtained, and the patient was discharged on (b)(6) 2025.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed crea_2 results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed creatinine_2 (crea_2) results obtained on multiple patient samples on an atellica ch 930 analyzer.Siemens is evaluating the event.
Additional Manufacturer Narrative
Additional information (28-mar-2025): siemens review of the reagent data indicated that the reagent arm 1 detected multiple level sense issues during the first 12 aspirations from the pack, including 3 failures to detect the transition between air and liquid.The data indicated that the reagent arm 1 continued to aspirate below the reagent surface after adjusting the aspiration location.The instrument did not flag aspiration errors and continued to produce results.Siemens is evaluating the event.Initial mdr 2432235-2025-00087 was filed on 13-mar-2025.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00087 on 13-mar-2025 and first supplemental mdr on 17-apr-2025.Additional information (20-oct-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the data from the physical manufacturer of creatinine_2 (crea_2) assay.The manufacturer confirmed that there was no evidence of over or underfilling during dispense, but observed pack anomalies.However, siemens is unable to determine if the pack anomalies contributed to the erroneously depressed crea_2 results.No hardware anomalies were identified.A product problem was not identified.The device is performing according to 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, crumlin; registration # 8020890; 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: 21594062
• Report Number: 2432235-2025-00087
• Device Sequence Number: 15688136
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242279(17)250901
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 11/12/2025

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: 09/01/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097596
• Device Lot Number: 242279
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 10/20/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/17/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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