MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE

Catalog Number	K4086 SMN 10445128
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported that a discordant, falsely depressed vanc patient result was obtained on the dimension vista 500 system.The ccc representative reviewed the vista instrument data logs and found no process errors or any other related issues.Siemens headquarters support center (hsc) has completed their evaluation of the event and information provided.Vanc quality control (qc) recovery at the time of this event was within acceptable ranges.No product nonconformance with the instrument or reagent was identified.The device is operating within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely depressed vancomycin (vanc) result was obtained on a patient sample on the dimension vista 500 system.The result was reported to the physician(s).The same sample was repeated on the same instrument and on an alternate vista instrument and a higher result was obtained.A corrected result was issued.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed vancomycin (vanc) result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7506193
• Report Number: 2517506-2018-00296
• Device Sequence Number: 1225073
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: 00842768015533
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• 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): 05/11/2018

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 Expiration Date: 10/26/2018
• Device Catalogue Number: K4086 SMN 10445128
• Device Lot Number: 17299AC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1