MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS 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	06/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report a falsely elevated glucose (glu) result that was obtained on one patient sample on a dimension vista 500 instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.Quality controls (qc¿s) recovered out of range after the affected sample was processed.The cse replaced and aligned the aliquot probe, cleaned the sample and integrated multisensor technology (imt) probes, replaced the reagent arm 1 (r1) mixer, aligned the r1, replaced the imt pump tubing, and aligned the imt and photometer.Then, the cse performed a full quick check, r1 service methods, and qc and all tests passed.Siemens reviewed the information provided and concluded that the gel formation on aliquot, sample, and imt probes and r1 mixer malfunction, which was addressed by the service activities above, 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 a falsely elevated glucose (glu) result was obtained on one patient sample on a dimension vista 500 instrument.The sample was diluted and repeated on the same instrument.The erroneous diluted result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate dimension vista instrument twice.The repeat results obtained on the alternate dimension vista instrument were lower than the erroneous result.The repeat result of 87.68 mg/dl was reported, as the correct result, to the physician(s).The sample was repeated on the initial instrument after service activities were performed on the instrument.Upon reviewing the instrument data, siemens discovered multiple repeat sodium (na) and potassium (k) results for sample id (b)(6).The customer indicated that the initial results were reported to the physician(s) and no corrected reports were issued.The results for sample id (b)(6) were included in this mdr in an abundance of caution.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 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: sandeep sidhu ; 511 benedict ave.; tarrytown, NY 10591 ; 6093676267
• MDR Report Key: 22472402
• Report Number: 2517506-2025-00107
• Device Sequence Number: 15482031
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 06/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2018
• 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