MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Atellica CH; Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)

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	06/23/2026
Type of Reportable Event	Malfunction

• Brand Name: Atellica CH
• Common Device Name: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
• Manufacturer (Section D): Siemens Healthcare Diagnostics Inc.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; registration # 2517506; 500 gbc drive, po box 6101; newark DE 19714 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50097973
• Report Number: 2432235-2026-00177
• Device Sequence Number: 10368717
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: (01)00630414279206(10)150521(17)261027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/01/2026

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 Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 150521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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