MAUDE Adverse Event Report: DYNEX TECHNOLOGIES INC DSX; AUTOMATED ELISA SYSTEM

Model Number DSX

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 10/26/2016

Event Type  No Answer Provided  

Event Description

Dynex technologies inc - manufacturer of the dsx "open" automated immunoassay instrument.(b)(4) - distributor of immunoassay equipment and assays.Trinity biotech ((b)(4)) - manufacturer of trep-sure anti-treponema assay ((b)(6)).On december 4th 2016 (b)(6) reported to dynex technologies inc.That a (b)(6) using the trinity biotech ((b)(4)) trep-sure microplate assay on the dynex dsx analyzer had led to a patient receiving a liver biopsy for (b)(6).The biopsy was (b)(6).A retest of the (b)(6) was run and the new patient sample was found to be (b)(6).The patient has since been diagnosed with (b)(6).(b)(6) hospital, on review of the data, discovered erratic results which they claim may be caused by the dsx analyzer, serial number (b)(4).Dynex commenced an investigation and found the following: the instrument's pipette module had been replaced on 6th december by dynex field service at alere's request (the company who placed the instrument and trained the users at (b)(6) hospital).The pipette module was sent back to dynex technologies.The pipette module was tested extensively and found to be in specification.Dynex has found that the dsx automated pipetting system at (b)(6) is being operated with consumables that are outside permissible limits relative to the configuration settings.Further, an unsupported practise of inserting undefined sample tubes in order to accommodate low sample volumes is routinely employed.Both practises provide the potential for erroneous results related to the pipetting of samples and reagents.Dynex has concluded that the dsx system is not malfunctioning but has identified processes in the laboratory that might potentially lead to erroneous results.

• Brand Name: DSX
• Type of Device: AUTOMATED ELISA SYSTEM
• Manufacturer (Section D): DYNEX TECHNOLOGIES INC; 14340 sullyfield circle; chantilly; VA 20151 1621
• Manufacturer Contact: candice prowse ; 14340 sullyfield circle; chantilly, VA 20151-1621 ; 5714550811
• MDR Report Key: 6219731
• MDR Text Key: 63769848
• Report Number: 1117676-2016-00003
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSX
• Device Catalogue Number: 65100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other