MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; 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	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observation of an erroneously elevated calcium (ca) result when processed on dimension vista 500 system (s/n: (b)(6)).An initial elevated result was obtained for the patient in question.The initial result was reported to the physician but was not questioned.The same sample was then retested on the original system and obtained a lower result.The lower result was considered correct and was issued on the corrected report to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment due to the reported event.
Additional Manufacturer Narrative
A united states customer contacted siemens and reported observation of an erroneously elevated calcium (ca) result when processed on dimension vista 500 system.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse performed a service visit and ran service methods on server 1, identifying r1 mix, s1 align, and r2 align out of specification.All probe horizontal and vertical belts were inspected and found to be acceptable.The r1 mixer was replaced, the probe was auto aligned, and bocc (bottom of cuvette) was performed on the s1 and r2 probes.Post-service verification, the cse confirmed server 1 was within specification.The ca result monitor was reset, calibration was acceptable, and qc recovered within acceptable ranges for both assays and no abnormal flags were observed.No additional events were reported by the customer.Siemens further evaluated the event and determined that the probable cause was consistent with mixing and alignment issues, which were resolved using routine troubleshooting actions.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA
• 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: 24160324
• Report Number: 2517506-2026-00013
• Device Sequence Number: 9001120
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/23/2026

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: 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• 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