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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report the incident.A siemens customer service engineer (cse) was dispatched to the site to inspect the instrument.The cse observed that the sample probe 1 was out of alignment, giving vertical motor in motion mismatch errors and clog detect errors.The cse replaced the sample 1 vertical belt.An s1 diagnostic sequence and an automatic alignment of probes sequence was performed.The quick check diagnostic test was performed and quality control material were run with acceptable results.The cause of the discordant, falsely low carbon dioxide (co2) test results was due to a worn belt on the sample probe 1 mechanism.The instrument is performing according to the specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low carbon dioxide (co2) test results were obtained for two patient samples on a dimension vista 500 instrument.The initial results were reported to the physician(s).The same samples were repeated on the same dimension vista 500 instrument and an alternate dimension vista 500 instrument.The repeat results were not reported to the physician(s).Both patients were redrawn and tested for carbon dioxide (co2) on the alternate dimension vista 500.The test results for the redraws were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low carbon dioxide (co2) test 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
• MDR Report Key: 7483746
• Report Number: 2517506-2018-00321
• Device Sequence Number: 1716765
• Product Code: JJE
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1