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	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc) to report a falsely depressed carbon dioxide (co2) patient result that was obtained on a dimension vista 500 instrument.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse replaced the sample mixer and the controller area network (can) board on the reagent 2 pump panel.Siemens further investigated the issue and determined that the co2 reaction was flat after the sample was added and the result monitor demonstrated sample mixer issues.Therefore, siemens concluded that the malfunctioned sample mixer potentially contributed to the falsely low carbon dioxide result.After the service visit, the instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 500 instrument.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate dimension vista 500 instrument.The repeat result was higher than the discordant result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed co2 result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2517506-2021-00295 on 28-oct-2021.Additional information (06-oct-2021): in the initial report, siemens indicated that a siemens customer service engineer (cse) was dispatched to the customer's site.In addition to replacing the sample mixer, the cse performed alignments and ran a quick check.Then, the cse determined that the autocheck and quality control recovered acceptably.The customer indicated that only one patient sample was affected by this issue, which was reported in the initial report.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; newark DE 19714 6101
• MDR Report Key: 12715374
• Report Number: 2517506-2021-00295
• Device Sequence Number: 4489198
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1