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	02/11/2025
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 twenty-two (22) patient samples on an atellica ch 930 analyzer.The erroneously depressed results were reported to the physician(s), and the results were not questioned.The same samples were reprocessed on the original atellica ch 930 analyzer.Higher reprocessed results were obtained and considered correct.Corrected reports were issued.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
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed creatinine_2 (crea_2) results obtained on twenty-two (22) patient samples on an atellica ch 930 analyzer.Siemens reviewed the available instrument data files and the information provided by the customer.Quality control (qc) recovered within range prior to running patient samples on the event date.The customer ran out of reagent and moved to a new reagent well.When the erroneously depressed crea_2 results were obtained, the customer ran qc on a new reagent well, which recovered out of range.The customer performed a lot calibration as a standard troubleshooting procedure.The customer rejected crea_2 calibration due to low response values compared to alternate crea_2 calibrations.The customer moved to another reagent pack and ran qc and calibration, which recovered acceptably.Siemens determined that the compromised reagent well of unknown cause potentially contributed to the erroneously depressed crea_2 results.The issue was resolved with standard troubleshooting procedures, including a lot calibration on another reagent well.The analyzer is operational.Siemens is evaluating the event to identify the cause of the compromised reagent well.
Additional Manufacturer Narrative
Additional information (07-apr-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens' further review of the instrument data indicated that the reagent 1 arm did not detect reagent at the expected fill height when entering the new reagent pack.The analyzer recorded zero level-sense transitions and an aspiration pressure error during the first aspiration attempt.The analyzer corrected for the lower reagent volume and continued processing from the pack well, which led to erroneous results.Level-sense data indicated that well 1 of the reagent pack was lower than expected fill.However, there was no hardware issue that contributed to the reported event.As indicated in the initial mdr, the compromised reagent well of unknown cause potentially contributed to the erroneously depressed 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 siemens investigation.Initial mdr 2432235-2025-00077 was filed on 06-mar-2025.

• 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: 21534665
• Report Number: 2432235-2025-00077
• Device Sequence Number: 18053108
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242279(17)250901
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/18/2025

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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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