MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® 500 SYSTEM

Model Number	DIMENSION VISTA® 500 SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two (2) discordant falsely depressed vancomycin (vanc) patient sample results were obtained on a dimension vista® 500 intelligent lab system.The falsely depressed patient results were not reported to the physician(s).The same sample was reprocessed on an alternate dimension vista® 500 intelligent lab system and the original system.Higher results were obtained and considered correct.One of the results obtained on the alternate dimension vista® 500 system was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed vancomycin (vanc) results.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding two (2) falsely depressed vancomycin (vanc) patient sample results obtained on a dimension vista® 500 intelligent lab system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.The cause of the event is sample specific due to poor sample quality impacting the proper sample aspiration and delivery of the sample to the cuvette.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® 500 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17244009
• Report Number: 2432235-2023-00201
• Device Sequence Number: 6708804
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 07/01/2023

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 Model Number: DIMENSION VISTA® 500 SYSTEM
• Device Catalogue Number: SMN 10488217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2018
• 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