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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center and reported that falsely depressed carbon dioxide (co2) results were obtained on two patient samples on the dimension vista 500 instrument.Quality control (qc) was in range on the day of event.When the customer called siemens, the customer indicated that they replaced a qgard water filter, but the system alerted to replace it.There were multiple water purification module (wpm) errors.Siemens remotely assisted the customer with reseating the qgard.The customer service engineer (cse) was dispatched to the customer's site.The cse installed pretreatment filters, replaced the ro membrane filter, allowed the system to rinse, and performed quickcheck, which recovered within acceptable limits.Qc also recovered within range.The instrument presented indicators of poor water quality and the co2 assay is sensitive to water quality.The customer had not reported any additional falsely depressed co2 results since installation of the pre-treatment filters and replacement of the ro membrane filter.Siemens reviewed the information provided and concluded the potential cause of falsely depressed co2 patient results was due to poor water quality that was resolved by the cse with installation of the pre-treatment filters and replacement of the ro membrane filter for the wpm.The instrument was performing within specifications.No further evaluation of this device is required.
Event or Problem Description
Falsely depressed carbon dioxide (co2) results were obtained on two patient samples on the dimension vista 500 instrument.The initial results were reported to the physician(s), who questioned the results.The samples were reprocessed on an alternate dimension vista 500 instrument.The sample identified as (b)(6) was also reprocessed on the original instrument.The repeat results were higher than the initial results.The repeat results from the alternate instrument were reported as correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2 patient results.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• 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: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 16254945
• Report Number: 2517506-2023-00017
• Device Sequence Number: 20183521
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/27/2023

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 500
• Device Catalogue Number: 10488217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2018
• 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