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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
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 instrument.The initial result was not reported to the physician.The sample was repeated on the original and on an alternate dimension vista 500 instrument.The repeat results matched the patient¿s clinical condition and were considered correct.The repeat result from the original instrument was reported as the correct result to the physician.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 the siemens customer care center (ccc) and reported that a falsely elevated potassium (k) result obtained on a patient sample on a dimension vista 500 instrument.Siemens reviewed the instrument data and observed quality control (qc) results were within lab range prior to running patient samples.The dilution check correction factor, calibration, air values of standard a (std a), std b and pump rate were within the normal range.Through siemens remote assistance, the customer replaced the v-lyte diluent bottle, primed all the integrated multisensor technology (imt) fluids, cleaned the imt drain using the cleaning tool brush, replaced and realigned the imt probe.The customer disconnected imt probe and reseated the imt tubings, and ran check 1, which passed acceptably.Further, the customer realigned the pump cycle.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse cleaned and detailed the imt and rotary valve, replaced peristaltic pump tubing, performed auto alignment on the imt, ran read cycles, which passed.Then the cse adjusted pump rate and performed a full quick check, which passed acceptably.Next, the cse ran dilution check and qc, which recovered within acceptable ranges.The cause of the falsely elevated k result is unknown.The instrument was performing within specifications.No further evaluation of this device is required.

• 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 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: 22528598
• Report Number: 2517506-2025-00113
• Device Sequence Number: 12618770
• 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): 07/17/2025

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: 06/24/2025
• Initial Report FDA Received Date: 07/17/2025
• 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: Female