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

Model Number	DIMENSION VISTA 500 SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated potassium (k) result was obtained on a patient sample on a dimension vista 500 system.The erroneous result was not reported to the physician(s).The sample was repeated on the original dimension vista 500 system and on an alternate dimension vista system.The repeat results recovered lower than the initial result and within the normal range.The repeat results obtained from both the system were considered correct and the repeat result obtained from the original system was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated k result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated potassium(k) result was obtained on a patient sample on a dimension vista 500 system.Quality control (qc) was acceptable on the day of the event.Siemens reviewed the system integrated multisensor technology (imt) data and observed that dilution check correction factor was within the limit, calibration, air values of std a and std b and pump rate were within the normal range on the day of the event.Siemens remotely assisted the customer and checked the qc and imt calibration data.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse identified that an aliquot probe with sticky stuff inside, replaced and aligned aliquot probe, performed power flush, cleaned and aligned rotary valve, cleaned all tubings and ports, primed with random patient plasma and performed dilution check, which passed.Further, the cse ran qc and a quick check, which recovered acceptably.Siemens further evaluated the event and concluded that the sticky stuff inside the aliquot probe, which was corrected by replacing and aligning aliquot probe, potentially contributed to the falsely elevated k result.The instrument is performing according to specifications.No further evaluation of this device 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22517869
• Report Number: 2517506-2025-00111
• Device Sequence Number: 8633652
• 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): 07/16/2025

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 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: 07/02/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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