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	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center to report a discordant, falsely low carbon dioxide result obtained on a dimension vista 500 instrument.A siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse found an issue with the reagent (r1) tubing, mixer, horizontal, and vertical belt.The reagent (r1) arm, reagent (r1/r2) manifold, and reagent (r2) e-chain were replaced.Reagent (r1 & r2) probes were aligned to the bottom of cuvette correction (bocc).Service methods passed and all qc was in range.Siemens concluded that it was not a reagent or method issue and that the cause of the event could not be traced back to a specific component that was replaced.The parts replaced by the cse is part of normal troubleshooting and maintenance for issues of this nature.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low carbon dioxide patient result was obtained on a dimension vista 500 instrument.The initial discordant result was not reported to the physician(s).The sample was repeated on an alternate dimension vista 500 instrument, resulting in a higher value.The repeat result was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant result.

• 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: 9177055
• Report Number: 2517506-2019-00382
• Device Sequence Number: 2692972
• Product Code: JJE
• UDI-Device Identifier: 00842768015090
• UDI-Public: 00842768015090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 10445143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1