MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted siemens regarding one (1) erroneously depressed urinary/cerebrospinal fluid protein (ucfp) patient sample result obtained on an atellica ® ch 930 analyzer.The erroneously depressed patient result was not reported to the physician(s).The same sample was reprocessed on an alternate atellica ® ch 930 analyzer.A higher result was obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed urinary/cerebrospinal fluid protein (ucfp) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed urinary/cerebrospinal fluid protein (ucfp) result obtained on patient sample when processed on an atellica ® ch 930 analyzer.Siemens healthcare diagnostics is investigating the event.
Additional Manufacturer Narrative
Additional information (22-oct-2024): siemens healthcare diagnostics service operations support (sos) team (formerly headquarters support center (hsc) concluded the investigation of the event.Sos reviewed the instrument data files and the information provided by the customer.No reagent or instrument issues were identified.The cause of the event is unknown.The customer is operational.A potential product issue was not identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2432235-2024-00225 was filed 09-oct-2024.
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, investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2024-00225 was filed on 09-oct-2024.Supplement 1 mdr 2432235-2024-00225 was filed on 30-oct-2024.

• Brand Name: ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• Common Device Name: 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.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20410112
• Report Number: 2432235-2024-00225
• Device Sequence Number: 15483509
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: (01)00630414279206(10)140135(17)250408
• 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,Followup
• Report Date (Section B): 08/18/2025

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: 04/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097543
• Device Lot Number: 140135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2024
• Supplement Date Received by Manufacturer: 10/22/2024; Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/30/2024; 08/18/2025
• Date Device Manufactured: 04/16/2024
• 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
• 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