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

Catalog Number K6410 SMN 10445103

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

Mdrs 2517506-2019-00477, 2517506-2019-00478, 2517506-2019-00480, 2517506-2019-00481 were filed for the same event.The customer contacted the siemens customer care center (ccc) and reported a depressed free thyroxine (ft4) patient result was obtained on a dimension vista 1500 instrument.Siemens is investigating the event.

Event Description

A discordant, falsely depressed free thyroxine (ft4) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s) and questioned.The same sample was reprocessed at an alternate facility on a non-siemens alternate methodology and on an alternate siemens methodology and higher correct results were obtained.There are no known reports of adverse health consequences due to the discordant depressed ft4 result.

Manufacturer Narrative

Mdr 2517506-2019-00479 was filed on 18-dec-2019.Mdrs 2517506-2019-00477, 2517506-2019-00478, 2517506-2019-00480 and 2517506-2019-00481 were also filed for the same event on 18-dec-2019.Additional information (19-dec-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed free thyroxine (ft4) result.Hsc evaluated the information provided and the instrument data files.There was no indication of instrument issues when the patient's samples were processed.The results of the heterophilic antibody blocking (hab) treatment on the patient sample indicated a difference in recovery indicative of a sample specific interferent.As stated in the instructions for use (ifu) for free thyroxine (ft4) on the dimension vista; "patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed." the cause of the discordant ft4 result is due to a sample specific interferent.The patient sample was not requested to be returned for evaluation because the customer was able to perform adequate testing to determine the cause.This event is singular in nature and is limited to a single patient sample.The instrument is operational.No product non-conformance identified.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA®
• Type of Device: 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: 9492039
• MDR Text Key: 191178154
• Report Number: 2517506-2019-00479
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00842768015205
• UDI-Public: 00842768015205
• Combination Product (y/n): N
• PMA/PMN Number: K140859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Catalogue Number: K6410 SMN 10445103
• Device Lot Number: 19231BC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1