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

Model Number	DIMENSION VISTA 500
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	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneous results for assays including but not limited to carbon dioxide (co2), calcium (ca), and glucose (glu) on an unspecified number of patient samples were obtained on a dimension vista 500 instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse verified the performance of the analyzers located at the customer site by routine service actions to verify the mixer performance, water quality, optics, and water distribution.The cse identified that the water purification module (wpm) was overfilling and leaking, replaced wpm sensor and cleaned the wpm module, ran calibration, quality control (qc) and troubleshooting testing, for which the results were obtained within acceptable ranges.Siemens further evaluated the event and determined that the water purification module (wpm) issue potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneous results for assays including but not limited to carbon dioxide (co2), calcium (ca), and glucose (glu) on an unspecified number of patient samples were obtained on a dimension vista 500 instrument.The erroneous results were reported to the physician(s).It is unknown if the results were questioned.The samples were repeated on an alternate dimension vista 500 instrument and obtained correct results that matched the clinical picture of the affected patients.Corrected reports were issued to the physician(s) based on repeat testing.The customer declined to provide sample data.There are no known reports of patient intervention or adverse health consequences due to the reported event.

• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21932859
• Report Number: 2517506-2025-00069
• Device Sequence Number: 21031664
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/30/2025

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: 04/05/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2014
• 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