MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC) TAQPATH COVID-19 COMBO KIT

Catalog Number A47814

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

False positive calls for the single viral target rendered seven patient wells inconclusive instead of true negative, requiring re-test of the samples.For sample (b)(6), the optical mixing issue caused both orf1ab and s gene amplification curves across the threshold, which resulted in a false positive call at the sample level.This sample was sent to another lab to be tested with taqpath eua workflow and was confirmed to be negative.During investigation we determined that the plate mixing issues caused the call in a single well (1 patient) to change from true inconclusive to positive, constituting a false positive.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer concluded that the false amplification was due to user error.Specifically, the user did not properly vortex and/or centrifuge the qpcr plate according to ifu instructions and provided training materials.

Event Description

Customer reported runs with a single viral target (orf1ab) called as positive in the interpretive software when there was no real amplification.Instruments: kingfisher flex and quantstudio 5 0.2ml block s/n (b)(4).All pipetting were manually done.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer concluded that the false amplification of orf1ab was due to user error.Specifically, the user did not properly vortex and/or centrifuge the qpcr plate according to ifu instructions and provided training materials.No false results were reported to patients or their healthcare providers, nor was any clinically-significant delay in diagnosis reported.The customer reported no patient deaths or serious injuries to thermo fisher scientific.Customer has been re-trained by their field applications scientist and is no longer experiencing these issues.

• Brand Name: TAQPATH COVID-19 COMBO KIT
• Type of Device: TAQPATH COVID-19 COMBO KIT
• Manufacturer (Section D): LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC); 6055 sunol boulevard; pleasanton, ca
• Manufacturer (Section G): LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC); 6055 sunol boulevard; pleasanton, ca
• Manufacturer Contact: kelli tanzella ; 3175 staley rd; grand island, ny
• MDR Report Key: 10452021
• MDR Text Key: 231800884
• Report Number: 3009976420-2020-00009
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A47814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1