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

Model Number	DIMENSION VISTA 500 SYSTEM
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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a discordant glucose (glu) result was obtained on a patient sample on a dimension vista 500 system.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse confirmed that the system was showing bias on patient samples.The cse checked all mixers bottoms and alignments.The cse adjusted reagent probe 1 (r1) and auto aligned r1 twice due to the bottom of the cuvette calibration.The cse ran a full autocheck and ran a precision check with patient samples.The precision check was found to be within acceptable ranges.The customer ran quality controls (qc) to verify.The instrument is performing according to specifications.Siemens is investigating the event.
Event or Problem Description
The customer reported a discordant glucose (glu) result was obtained on a patient sample on a dimension vista 500 system.There are no known reports of patient intervention or adverse health consequences due to the discordant glucose (glu) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2026-00002, on 02-jan-2026.Additional information (24-jan-2026) siemens further evaluated the event by reviewing the available information in the complaint and concluded that the probable cause of the event was misalignment of reagent probe 1 (r1).R1 auto-alignment was performed when a customer service engineer visited the site.A precision test was run subsequently, the results of which were within acceptable limits.An autocheck and quality controls (qc) were run; both of which recovered within acceptable limits.No additional occurrences of the behavior were reported by the customer.The complaint was resolved with routine troubleshooting actions.The customer is operational.The investigation conclusions code in section h6 was updated to reflect the additional information.No further evaluation of this analyzer is required.

• Brand Name: DIMENSION VISTA 500 SYSTEM
• 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: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 23943844
• Report Number: 2517506-2026-00002
• Device Sequence Number: 18812345
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 Model Number: DIMENSION VISTA 500 SYSTEM
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2015
• 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