MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP); BIURET (COLORIMETRIC), TOTAL PROTEIN

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	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding falsely depressed erroneous urinary/cerebrospinal fluid protein (ucfp) results obtained on four (4) patient samples on an atellica ch 930 instrument.The samples were reprocessed due to the quality control recovering outside qc ranges.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported falsely depressed urinary/cerebrospinal fluid protein (ucfp) results were obtained on four (4) patient samples on an atellica ch 930 instrument (s/n (b)(6) ).The erroneous results were reported to the physician(s) and were not questioned.The same samples were reprocessed on an alternate atellica ch 930 instrument (s/n (b)(6) ).The reprocessed higher results obtained were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed urinary/cerebrospinal fluid protein (ucfp) results.
Additional Manufacturer Narrative
Additional information (05-aug-2025): siemens healthineers has confirmed, through an internal investigation of customer complaints, the potential for falsely depressed patient, quality control (qc), and/or calibration results.The observations have been isolated to the initial replicate(s) of a freshly punctured atellica ch ucfp reagent well that has been stored onboard the system.The issue is intermittent and will not occur in all packs or wells.The issue may be observed with all sample types (urine and cerebrospinal fluid) for any atellica ch ucfp reagent lot on an atellica ch or ci analyzer.The maximum negative bias observed during the investigation was -19.0 mg/dl (-190 mg/l).Us customers were notified through urgent medical device correction (umdc letter achc25-07.A.Us), titled ¿potential for falsely depressed results with the atellica ch ucfp assay¿ and ous customers were identified through urgent field safety notice (ufsn letter, achc 25-07.A.Ous) of the potential for falsely depressed patient, quality control (qc), and/or calibration results.The umdc and ufsn provide instructions for customers to perform qc on each well.The customer is operational.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2024-00141 was filed on 25-jun-2024.

• Brand Name: ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: BIURET (COLORIMETRIC), TOTAL PROTEIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 19605916
• Report Number: 2432235-2024-00141
• Device Sequence Number: 8486141
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: 00630414279206
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 07/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 130273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 07/05/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-08/13/2025-004-C
• Patient Sequence Number: 1
• Patient Sex: Unknown