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

Catalog Number	10282969
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they received a falsely elevated hba1c results compared to retesting performed on the same device.The controls were passing.There is no report of injury due to this event.
Additional Manufacturer Narrative
Siemens has completed the investigation.Testing was performed on returned reagent using in-house dca vantage instruments and analysis was completed using test solution one, which has an assigned value of 5.35%.Cassettes tested using the test solution one produced the expected values.The customer's report of falsely elevated test result was not reproduced.Customer states that quality control is passing, and they are operational.The cause of the event is unknown.No product problem identified.

• 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: 25076580
• Report Number: 3002637618-2026-00052
• Device Sequence Number: 10402750
• Product Code: LCP
• UDI-Device Identifier: 00630414551364
• UDI-Public: (01)00630414551364
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/05/2026

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: 04/06/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown