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

Model Number	DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed creatinine (cre2) result was obtained on a patient sample on a dimension vista 500 intelligent lab system.The erroneous result was reported to the physician(s), who questioned the result.The sample was not repeated further.Prior to obtaining the erroneous result, three different samples were drawn from the same patient and processed on the original system.The results from these previously drawn samples were higher than the erroneous result and were reported to the physician(s).After the erroneous result was obtained, two new samples were drawn from the same patient and processed on the original system.The results from the newly drawn samples were also higher than the erroneous result and were reported to the physician(s).The higher results obtained from these five samples were considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed cre2 result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed creatinine (cre2) result was obtained on a patient sample on a dimension vista 500 intelligent lab system.Calibration was acceptable, and quality control (qc) was within the range on the day of the event.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2025-00141 on 10-sep-2025.Additional information (18-sep-2025): siemens reviewed the instrument data and observed no performance errors.Based on the available information, the cause of the falsely depressed creatinine (cre2) result is unknown.The investigation findings and investigation conclusions codes of section h6 were updated to reflect the additional information.The system is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM
• Common Device Name: DIMENSION VISTA 500 INTELLIGENT LAB 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: 23013385
• Report Number: 2517506-2025-00141
• Device Sequence Number: 9539238
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/08/2025

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 INTELLIGENT LAB 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2014
• 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 Age: 78 YR
• Patient Sex: Male