MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Dimension Vista; Dimension Vista Vancomycin Flex reagent cartridge

Catalog Number	10445128
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously depressed vancomycin (vanc) result on a patient sample was obtained on a dimension vista 500 system.The initial result was reported to the physician and questioned.The same sample was repeated on both original and alternate dimension vista 500 systems.The repeat results obtained were higher than the initial result, matched the clinical history and were considered correct.The repeat result from an alternate system was reported as the correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding an erroneously depressed vancomycin (vanc) result on a patient sample obtained on a dimension vista 500 system.Siemens reviewed the instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on calibration and quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.Based on the available information, the cause of the erroneous result was unable to be determined.The customer is operational.The device is performing according to specifications.No further evaluation is required.

• Brand Name: Dimension Vista
• Common Device Name: Dimension Vista Vancomycin Flex reagent cartridge
• Manufacturer (Section D): Siemens Healthcare Diagnostics Inc.; 500 gbc drive; po box 6101; newark DE 19714 -610
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; 500 gbc drive; po box 6101; newark DE 19714 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50733087
• Report Number: 2517506-2026-00140
• Device Sequence Number: 10591439
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: (01)00842768015533(10)26069AA(17)270310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• 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): 09/11/2026

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: 10445128
• Device Lot Number: 26069AA
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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