MAUDE Adverse Event Report: DYNEX TECHNOLOGIES AGILITY; AUTOMATED ELISA SYSTEM

Model Number AGILITY

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Agility customers are being contacted by an important notice technical bulletin to clarify the best practice to follow when aborting a rack where not all sample ids have been successfully read.Software improvements will be introduced shortly to eliminate the risk of assay results linked to the wrong sample ids due to sample racks being swapped without clearing the original sample ids.

Event Description

Quest diagnostics-agility running quantiferon qft-tb gold plus assay;13 incorrect assigned sample ids.Root cause: a sample barcode is not successfully scanned by the analyzer, the user ignores the on-screen sample tracking, also color coded led on the sample lanes and then scans new samples prior to clearing the rack.The agility is an open system used for automating elisa assays.Test samples are loaded in a sample rack, and the sample identification (sid) barcodes on the individual tubes are read and stored in the agility sid memory, to which assay results are then linked.Failed barcode scans are repeated until all samples in the rack have been successfully read.On investigation it was established that sample racks had been swapped without first cancelling the original sids.Agility users are trained that if a rack is to be aborted before all the sids have been successfully scanned, they must clear the sid memory for the rack by loading a completely empty rack; failure to do this can cause replacement sample assay results to be incorrectly linked to the original sample ids in the sid memory and no results will be reported against the replacement sample ids.According to the qft-tb gold elisa package insert (03/16), limitations:"results for qft testing must be used in conjunction with each individual's epidemiological history, current medical status, and results of other diagnostic evaluations"."the predictive value of a positive qft result in diagnosing m.Tuberculosis infection depends on the probability of infections, which is assessed by histological, epidemiological, diagnostic and other findings.A diagnosis of latent (b)(6) infection requires that (b)(6) must be excluded by medical evaluation including assessment of current medical and diagnostic disease as indicated.A negative result must be considered with the individual's medical and historical data relevant to probability of (b)(6) infection and potential risk of progression to (b)(6), particularly for individuals with impaired immune function.Negative predictive values are likely to be low for persons suspected to have (b)(6) disease and should not be relied on to exclude disease".

• Brand Name: AGILITY
• Type of Device: AUTOMATED ELISA SYSTEM
• Manufacturer (Section D): DYNEX TECHNOLOGIES; 14340 sullyfield circle; chantilly VA 20151 1621
• Manufacturer Contact: candice prowse ; 14340 sullyfield circle; chantilly, VA 20151-1621 ; 7038031218
• MDR Report Key: 8623089
• MDR Text Key: 203699484
• Report Number: 1117676-2019-00001
• Device Sequence Number: 1
• Product Code: JJQ
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AGILITY
• Device Catalogue Number: 67000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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