MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; 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	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed urinary/cerebrospinal fluid protein (ucfp) result obtained on a patient sample on an advia® 2400 clinical chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported one (1) erroneously depressed urinary/cerebrospinal fluid protein (ucfp) patient sample result was obtained on an advia® 2400 clinical chemistry system.The erroneously depressed patient result was not reported to the physician.The same sample was reprocessed on an alternate advia® 2400 clinical chemistry system.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
Additional information (19-nov-2024): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer and instrument data.Quality control (qc) recovered within the customer's acceptable ranges.No reagent or instrument issues were identified.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2432235-2024-00219 was filed on 03-oct-2024.

• Brand Name: ADVIA CHEMISTRY
• 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 ; 511 benedict ave; tarrytown, NY 10591
• MDR Report Key: 20356153
• Report Number: 2432235-2024-00219
• Device Sequence Number: 8059389
• Product Code: CEK
• UDI-Device Identifier: 00630414279176
• UDI-Public: (01)00630414279176(10)160(17)250228
• 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): 12/06/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 11319151
• Device Lot Number: 160
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/06/2024
• Date Device Manufactured: 02/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown