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	01/03/2025
Type of Reportable Event	Malfunction
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 eight (8) patient samples on an atellica ch 930 analyzer.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the available instrument data files and the information provided by the customer.Calibration was acceptable, and quality control (qc) recovered within range on the event date.Based on the available information, the cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that erroneously depressed creatinine_2 (crea_2) results were obtained on eight (8) patient samples on an atellica ch 930 analyzer.The erroneously depressed results were reported to the physician(s).The patients were undergoing dialysis, and the samples were drawn monthly as part of their treatment.New samples were drawn from the same patients on (b)(6) 2025 and processed on an alternate atellica ch 930 analyzer except for the sample identifier: (b)(4).The newly drawn sample results were higher than the initial results and consistent with the patient¿s history.The newly drawn sample results were reported to the physician(s).After reviewing the newly drawn sample results, the physician(s) questioned the results from on (b)(6) 2025.The samples from on (b)(6) 2025 were not reprocessed due to the delay in questioning the erroneous results.For sample identifier: (b)(4), the patient did not have any sample draws on (b)(6) 2025, which led the customer to provide the previously drawn correct reported result from on (b)(6) 2024 obtained on an alternate atellica ch 930 analyzer, which was higher than the result from on (b)(6) 2025.No corrected reports were issued for the original samples.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed creatinine_2 (crea_2) results.

• 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; 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: 21888377
• Report Number: 2432235-2025-00120
• Device Sequence Number: 17032488
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242178(17)250501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/23/2025

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: 05/01/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097596
• Device Lot Number: 242178
• 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: 04/02/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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