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

Model Number	DIMENSION VISTA 1500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens customer care center and noted that the quality control (qc) and calibration were valid at the time of the event.The customer ran carbon dioxide (co2) precision studies on the instruments and noted that dimension vista 1500 system with serial number (b)(4) failed due to a sample probe (s3) mixer malfunction.Siemens noted the progard was replaced on (b)(6) 2023 and installed correctly along with the q-guard.Maintenances performed for sample probe (s3) and reagent probe (r5) included cleaning the drains, cleaning the linear bearings, and inspecting the probes and belts.The customer noted no issues.An auto-alignment was performed for s3 and r5, along with full system checks with a naoh (sodium hydroxide) clean and cuvette washer clean, and passed with no errors.The customer ran qc for all server 3 methods and noted that co2 qc passed without issue; however, the system failed a precision rerun study.Siemens dispatched a customer service engineer (cse) to the customer site.The cse moved the assays from server 3 to server 2 until services were performed.The cse performed troubleshooting, which included running service methods, and noted a failure with the mixer.The cse serviced the system and replaced the s3 mixer to resolve the problem.Siemens verified the system operates as specified, and no further evaluation was required.
Event or Problem Description
The customer observed 38 falsely depressed carbon dioxide (co2) results for different patients on a dimension vista 1500 system.The results were reported and questioned by the physician(s).The customer used the same samples to perform repeat testing on an alternate dimension vista 1500 system.The repeat results were higher and reported to the physician(s) as the correct results.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed carbon dioxide (co2) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2517506-2023-00093 on 13-mar-2023.Correction information (25-feb-2023): the initial mdr included the incorrect date in section g3 "date received by manufacturer".Siemens confirmed the correct is 24-feb-2023.Additional information (13-mar-2023): siemens reviewed the information provided and services performed and concluded that the cause of falsely depressed carbon dioxide (co2) results was due to a malfunctioning sample probe 3 mixer.The investigation found no reagent lot or method issue, or potential product issue.The dimension vista 1500 system was verified and fully operational post-service repair.The system operates as specified, and no further evaluation was required.Section h6 (investigation conclusions) was updated to reflect the additional information.The email address inputted under g1 contact office (and manufacturing site for devices) or compounding outsourcing facility was arbitrary inputted to comply with the character limit.The correct email address can be found in section b6.

• Brand Name: DIMENSION VISTA 1500
• Common Device Name: DIMENSION VISTA 1500
• 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 #: 1226181; brookfield CT 06804
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 16533277
• Report Number: 2517506-2023-00093
• Device Sequence Number: 7170728
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 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): Unknown
• 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): 03/21/2023

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
• Device Catalogue Number: 10459469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2018
• 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