MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Dimension Vista; Calcium Flex reagent cartridge

Catalog Number	10445160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously depressed calcium (ca) results on two patient samples were obtained on a dimension vista 1500 system.For sample id (b)(6), the initial result was not reported to the physician.This sample was repeated on an alternate dimension vista 1500 system.While the initial result of sample id (b)(6) was reported to the physician and not questioned.This sample was repeated on both original and on alternate dimension vista 1500 systems.All the repeat results obtained were higher, correlated clinically, and considered correct.The repeat results from alternate system were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding erroneously depressed calcium (ca) results on two patient samples obtained on a dimension vista 1500 system.Siemens evaluated the instrument data and the information provided by the customer.The calibration results and quality control (qc) results were acceptable on the day of the event.The review of instrument data found no abnormalities with the instrument performance related to the reported event at the time of samples ran and the data indicated that the erroneous patient results originated from one of the well map position in flex sequence.No other discrepancies were observed in the remaining well positions within the same flex sequence or other flex sequences.The customer blew a new well, ran qc, and found it to be acceptable.Based on the available information, the probable cause of the event is consistent to the well position of the flex sequence.The reported event was resolved with standard troubleshooting actions.The customer is operational.The device is performing according to specifications.No further evaluation is required.

• Brand Name: Dimension Vista
• Common Device Name: Calcium Flex reagent cartridge
• Manufacturer (Section D): Siemens Healthcare Diagnostics Inc.; 500 gbc drive po box 6101; po box 6101; newark DE 19714 -610
• Manufacturer (Section G): Siemens Healthcare Diagnostics Inc.; 500 gbc drive; po box 6101; newark DE 19714 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50835272
• Report Number: 2517506-2026-00143
• Device Sequence Number: 10248105
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061792
• 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): 09/21/2026

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 Expiration Date: 09/22/2026
• Device Catalogue Number: 10445160
• Device Lot Number: 25265AA
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown