MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA BETA HUMAN CHORIONIC GONADOTROPIN FLEX REAGENT CARTRIDGE

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that the falsely elevated beta human chorionic gonadotropin (bhcg) results were obtained on two patient samples with error flags on a dimension vista 1500 system.Quality control (qc) and calibration were acceptable before the erroneous results were obtained.Siemens reviewed the information provided by the customer and the available instrument data files.Siemens' review of the result calculation data did not reveal any concerns and results for other patient samples processed during the same period were consistent and reliable, suggested that the system was functioning normally.Based on the available information, siemens evaluated the event and determined that the cause of the event is unknown.The behavior was resolved by repeating the samples.The customer is operational.
Event or Problem Description
The customer reported that the falsely elevated beta human chorionic gonadotropin (bhcg) results were obtained on two patient samples with error flags on a dimension vista 1500 system.The initial results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate dimension vista 1500 system.The repeat results matched with clinical history and were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated bhcg results.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA BETA HUMAN CHORIONIC GONADOTROPIN FLEX REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24856133
• Report Number: 2517506-2026-00069
• Device Sequence Number: 9036667
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: (01)00842768015540(10)25230AA(17)260818
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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 Expiration Date: 08/18/2026
• Device Model Number: N/A
• Device Catalogue Number: 10445107
• Device Lot Number: 25230AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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