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

Catalog Number	SMN 11097543
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed urinary/cerebrospinal fluid protein (ucfp) result obtained on an atellica® ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed urinary/cerebrospinal fluid protein (ucfp) patient result was obtained on an atellica® ch 930 analyzer.Customer stated the urinary/cerebrospinal fluid protein (ucfp) is inaccurate, falsely depressed and inconsistent with the microalbumin_2 (alb_2) result.The falsely depressed patient result was not reported to the physician.The sample was not reprocessed.Customer stated they do not know the correct result because there is no ucfp reagent from other manufacturers to compare.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed urinary/cerebrospinal fluid protein (ucfp) patient result.
Additional Manufacturer Narrative
Additional information (10-oct-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.Calibration and quality control recovered within the customer's expected ranges.Hsc performed troubleshooting to aid in the investigation.Siemens technical support laboratory processed 20 random urine samples with the ucfp and ualb_2 assays.The ucfp methodology was consistent between the atellica ch 930 analyzer and the dimension vista system.The cause of the event is consistent with a sample specific interferent.A potential product issue was not identified.The customer is operational.Correction: hsc confirmed the correct sample id is (b)(6).The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2023-00245 was filed on 30-aug-2023.

• 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.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17651910
• Report Number: 2432235-2023-00245
• Device Sequence Number: 7502725
• 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): 10/31/2023

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: 09/19/2023
• Device Catalogue Number: SMN 11097543
• Device Lot Number: 120243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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