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	10/10/2023
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 urinary/cerebrospinal fluid protein (ucfp) patient sample results obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
Two (2) discordant falsely depressed urinary/cerebrospinal fluid protein (ucfp) results were obtained on a patient sample on an atellica ch 930 analyzer.The falsely depressed results were not reported to the physician(s).The same sample was reprocessed on the same atellica ch 930 analyzer with 1:10 dilution and obtained a falsely depressed result.The same sample was reprocessed on an alternate non-siemens instrument.A higher result considered correct was obtained and reported.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 (09-nov-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data logs.Quality control (qc) and calibration recovery were within the customer's acceptable ranges.All results demonstrated consistency and confirmed no protein was detected with the atellica ucfp methodology.Hsc performed troubleshooting to aid in the investigation.The ucfp methodology was consistent between the atellica ch 930 analyzer and the dimension vista system.The patient sample was unavailable for siemens internal testing.The cause of the event is consistent with a sample specific interferent.The customer and system are operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2023-00280 was filed on 23-oct-2023.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
• 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 number 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17986451
• Report Number: 2432235-2023-00280
• Device Sequence Number: 8171786
• Product Code: CEK
• UDI-Device Identifier: 00630414279206
• UDI-Public: 00630414279206
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/30/2023

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: 02/20/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097543
• Device Lot Number: 130062
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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