MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DCA VANTAGE

Catalog Number	10282969
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the dca vantage analyzer mixed results from two different patient samples tested with the unique sample identification (id).The dca generated results from a sample processed on patient-1, and combined the results from a patient-2 sample using the id of patient-2.While no results were displayed for the patient-1 id.Results were reported to physician.No delayed or unnecessary treatment/medical procedure.
Additional Manufacturer Narrative
The customer returned their system to siemens for physical inspection and investigation.An investigation was conducted on the returned device.As part of the investigation, the database was reviewed.No patient results were documented as reported.The root cause is unknown.Instrument is operating as intended.

• Brand Name: DCA VANTAGE
• Common Device Name: DCA VANTAGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; northern road; chilton industrial estate; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: felix akinrinola ; 333 coney street; walpole, MA 02032
• MDR Report Key: 21716453
• Report Number: 3002637618-2025-00023
• Device Sequence Number: 17342594
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: (01)00630414551364
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K071466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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 Catalogue Number: 10282969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown