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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens remote services center (rsc) regarding an erroneous beta human chorionic gonadotropin (bhcg) result obtained on a patient sample on a dimension vista 500 intelligent lab system.Siemens concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Quality control (qc) and calibrations recovered within the customer¿s expected ranges, indicating that the bhcg assay was performing acceptably.Siemens determined that the issue was isolated to a single patient sample and the cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that an erroneous beta human chorionic gonadotropin (bhcg) result on a patient sample was obtained on a dimension vista 500 intelligent lab system.The initial result was reported to the physician and was questioned.The same sample was reprocessed on the original dimension vista 500 intelligent lab system.The reprocessed result was considered correct and reported to the physician.The customer did not provide the patient sample data to siemens.There are no known reports of patient intervention or adverse health consequences due to the erroneous bhcg result.

• 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: 21854712
• Report Number: 2517506-2025-00063
• Device Sequence Number: 7768136
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: (01)00842768015540(10)24345AB(17)251210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/17/2025

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 Expiration Date: 12/10/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 10445107
• Device Lot Number: 24345AB
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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