MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number	DIMENSION VISTA 1500
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	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report that discordant sodium patient results were obtained on a dimension vista 1500 instrument.The customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse auto-aligned integrated multisensor (imt) and probe and ran all proc commands with no errors.Additionally, the cse replaced the aliquot probe and cleaned the dirty aliquot drain, ran a full system quick check, changed the sensor to a new lot, performed a dilution check and applied corrections.System was fully functional upon departure.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Multiple discordant sodium patient results were obtained on a dimension vista 1500 (sn: (b)(6)) instrument.The initial samples were reported to the physician(s) and questioned.New samples were repeated on an alternate dimension vista 1500 instrument.The repeat results were reported, as the correct results, to the physician(s).The customer could not provide the specific, discordant results.There are no known reports of patient intervention or adverse health consequences due to the discordant sodium patient results.

• Brand Name: DIMENSION VISTA 1500
• Common Device Name: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591
• MDR Report Key: 16991954
• Report Number: 2432235-2023-00121
• Device Sequence Number: 20574411
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• 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): 05/24/2023

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
• Device Model Number: DIMENSION VISTA 1500
• Device Catalogue Number: 10459469
• 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: 04/28/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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