MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH MICROALBUMIN_2 (¿ALB_2)

Catalog Number	11097610
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that an erroneously depressed microalbumin_2 (ualb_2) result was obtained on a patient sample on an atellica ci 1900 analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reported that an erroneously depressed microalbumin_2 (alb_2) result was obtained on a patient sample on an atellica ci 1900 analyzer.The initial result was not reported to the physician(s).The sample was retested multiple times with and without dilutions on the original analyzer as part of troubleshooting.Then, the sample was repeated with 1:100 manual dilution on the original analyzer and a higher result was obtained.The higher repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed alb_2 result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00297 on 24-nov-2025.Additional information (24-nov-2025): siemens healthcare diagnostics has concluded the investigation of the event.Siemens evaluated the instrument data, and the information provided by the customer.Calibration and quality control (qc) recovered acceptably.No system errors or events surrounding the patient's processing.No reported systemic observation.Siemens evaluated the event and determined that a sample-specific interferent potentially contributed to the erroneously depressed microalbumin_2 (alb_2) result.A product problem was not identified.The event is isolated to a single patient sample.The customer is operational.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH MICROALBUMIN_2 (¿ALB_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: 23630238
• Report Number: 2432235-2025-00297
• Device Sequence Number: 10314309
• Product Code: JIR
• UDI-Device Identifier: 00630414596310
• UDI-Public: (01)00630414596310(10)242327(17)251201
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 12/19/2025

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: 12/01/2025
• Device Catalogue Number: 11097610
• Device Lot Number: 242327
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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 Age: 52 YR
• Patient Sex: Female