MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CREATININE_2 (CREA_2)

Catalog Number	SMN 11097596
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 twenty-three patient samples on an atellica ci 1900 analyzer.The customer performed quality control (qc) after the erroneous results, and it recovered outside the customer's acceptable ranges.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the available instrument data files and the information provided by the customer.The customer performed a calibration and ran qc, which recovered within the customer's acceptable ranges.The review of the calibration data showed that the calibrator response values were not consistent with the prior calibrations, indicating that the reagent in the creatinine_2 well was compromised.Siemens concluded that the probable cause of the event is consistent with the compromised creatinine_2 well.The analyzer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed creatinine_2 (crea_2) results on twenty-three patient samples on an atellica ci 1900 analyzer.It is unknown whether the initial results were reported to the physician(s).The same samples were repeated on an alternate atellica ci 1900 analyzer.The repeat results were considered correct and reported to the physician(s).The customer stated that roughly half of the patients affected had delayed infusion treatment based on the initial results.The customer did not provide the sample ids for which the infusion treatment was delayed.There are no known reports of adverse health consequences due to the erroneously depressed creatinine_2 (crea_2) results and the delayed infusion treatment.

• 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; india 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22210083
• Report Number: 2432235-2025-00151
• Device Sequence Number: 8262822
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: (01)00630414596457(10)242377(17)260101
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/16/2025

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 Catalogue Number: SMN 11097596
• Device Lot Number: 242377
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/16/2025
• 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