MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500 SYSTEM

Model Number	DIMENSION VISTA 1500 SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated calcium (ca) results obtained on two patient samples on a dimension vista 1500 intelligent lab system.Calibration and quality control (qc) recovered acceptably.Siemens reviewed the instrument data files and the information provided by the customer and found kin check errors suggesting mixing problems.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the system and ran service methods.The reagent 1 (r1) mixer was out of range and the cse replaced the r1 mixer and ran alignments, bottom of cuvette correction (bocc), and auto check, which passed.The cse then reset the system and reran the service methods; the mixers and alignments were acceptable.The cse ran qc, which passed.Based on the available information, siemens determined that the cause of the erroneously elevated ca results is consistent with reagent mixing issues.The customer is operational.The instrument is performing according to the specifications.No further evaluation is required.
Event or Problem Description
The customer reported that they obtained erroneously elevated calcium (ca) results on two patient samples on a dimension vista 1500 system.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate dimension vista 1500 system.The repeat results recovered lower, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated ca results.

• Brand Name: DIMENSION VISTA 1500 SYSTEM
• Common Device Name: DIMENSION VISTA 1500 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.; registration number: 1226181; 101 silvermine road; 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: 24614509
• Report Number: 2517506-2026-00052
• Device Sequence Number: 10164419
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: (01)00630414949536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143720
• 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): 03/17/2026

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 1500 SYSTEM
• Device Catalogue Number: 10459469
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/17/2026
• 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