MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 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	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens healthcare diagnostics concerning the impact of biotin on the ft4 result.The cause for the discordant elevated ft4 result is unknown.The customer stated that the quality control was within specification.Mdr 2517506-2017-00574 and 2517506-2017-00575 were filed for the same event.Siemens is investigating the incident.
Event or Problem Description
A discordant elevated free thyroxine (ft4) result was obtained on a patient sample on the dimension vista 1500.The result was not reported to the physician.The same patient sample was tested at an alternate facility with an alternate methodology and a lower result was obtained.There are no reports of patient intervention or adverse health consequences as a result of the discordant elevated ft4 result.
Additional Manufacturer Narrative
The original mdr 2517506-2017-00573 was filed 7/11/2017.The ft4 assay has been tested for potential interference at biotin levels of 100, 250, 500, and 1200 ng/ml.Interference testing was performed following clinical laboratory standards institute (clsi) guidance at concentrations approximately equivalent to the levels listed in the ifu.Below is the biotin interference of dimension vista ft4.Test level: 1.4.Units: ng/dl.Biotin test level and % interference observed.1200 ng/ml *.500 ng/ml 37.6%.250 ng/ml 8.4%.100 ng/ml 1.5%.*result for sample with 1200 ng/ml biotin is above the analytical measurement range and percentage increase could not be calculated.The siemens investigation is continuing.
Additional Manufacturer Narrative
Original mdr 2517506-2017-00573 was filed 7/11/2017.2517506-2017-00573 supplement 1 was filed 8/22/2017.Siemens healthcare diagnostics concluded the investigation of potential interference of biotin on dimension vista ft4 results.The instructions for use for the dimension vista ft4 flex reagent cartridge has been revised to include in the limitations of procedure section the following statement: "specimens that contain biotin at a concentration of 100 ng/ml demonstrate a less than or equal to 10% change in results.Biotin concentrations greater than this may lead to falsely elevated results for patient samples.Results from patients taking biotin supplements or receiving high-dose biotin therapy should be interpreted with caution due to possible interference with this test.".

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® FT4 FREE THYROXINE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 6701677
• Report Number: 2517506-2017-00573
• Device Sequence Number: 10930134
• Product Code: CEC
• UDI-Device Identifier: 00842768015205
• UDI-Public: 00842768015205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2018

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: 01/12/2018
• Device Catalogue Number: K6410 SMN 10445103
• Device Lot Number: 17012BA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 07/28/2017; 01/04/2018
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/22/2017; 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR