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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely depressed high-sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension vista 500 instrument.Quality controls (qcs) and calibrations recovered within ranges on the day of the event.The instrument produced multiple luminescent oxygen channeling immunoassay (loci) errors; for example, loci detector shutter open check failed and loci detector returned zero-sum cycle.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the insert and cup of the loci, reset the loci baseline data and ran 50 standard assay illumination read (sairs).Quick check and qc were performed and recovered acceptably.On subsequent visits, the cse replaced the loci module, aliquot plate elevator coupler, and mouse and aligned the loci arm.All plates were unloaded, loci check 1 and 50 sairs were performed and the result monitor for all loci tests was reset.All tests were calibrated and recovered acceptably.Siemens further evaluated the event and concluded the aliquot plate elevator coupler and the loci module potentially contributed to the falsely depressed tnih result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported a falsely depressed high-sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension vista 500 instrument.The erroneous result was not reported to the physician(s).Triggered by a delta check, the sample was repeated on the same instrument.The repeat result was higher than the erroneous result and matched the patient¿s previous result of 5000 ng/l.The repeat result was reported, as the correct result, to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the falsely depressed tnih result.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• 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 #: 1226181; brookfield CT 06804
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21764016
• Report Number: 2517506-2025-00053
• Device Sequence Number: 8720969
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/03/2025

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 Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10284473
• 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: 03/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2012
• 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: Female