MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® FT4 FREE THYROXINE FLEX® REAGENT CARTRIDGE

Catalog Number	K6410 SMN 10445103
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00396 was also filed for the same event.The customer contacted siemens healthcare diagnostics concerning a falsely elevated free thyroxine (ft4) result.Siemens headquarters support center (hsc) concluded the investigation of the information provided.Hsc concluded the patient sample discrepant result was consistent with an interferent.In addition, siemens performed troubleshooting and cannot identify any issues with instrument performance.Quality control (qc) processed on the instrument performing the patient sample testing showed good instrument precision on the day of testing as well as over time.No other indication of instrument issues were identified in the data files.No product nonconformance has been identified.The customer was provided information regarding biotin interference in certain immunoassays.The device is operating within specifications.No further investigation is required.
Event or Problem Description
A discordant, falsely elevated free thyroxine (ft4) result was obtained on a patient sample on the dimension vista 500 system.The result was reported to the physician(s) who questioned the result.The same sample was processed on an alternate non-siemens instrument obtaining a lower result.The customer stated that the patient's scheduled dilation and curettage surgery was delayed.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ft4 result or the delay of the surgery.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® FT4 FREE THYROXINE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7647969
• Report Number: 2517506-2018-00397
• Device Sequence Number: 184285
• Product Code: CEC
• UDI-Device Identifier: 00842768015205
• UDI-Public: 00842768015205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140859
• 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): 06/28/2018

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: 11/30/2018
• Device Catalogue Number: K6410 SMN 10445103
• Device Lot Number: 17334BA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1