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

Model Number A47814

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Thermo fisher scientific's review of the patient results, run results, and additional data from the customer, showed that the root cause of false positive results was due to user error.

Event Description

A customer reported "sporadic" false positive results in approximately 45 out of 2,500 tested patient samples.Based on customer follow-up, customer indicated that no false results were reported to patients or their healthcare providers.The customer reported no patient death or serious injury to thermo fisher scientific.Thermo fisher scientific's review of the patient results, run results, and additional data from the customer, showed that the false positive results were due to user error.Specifically, the user did not properly vortex and/or centrifuge the qpcr plate according to ifu instructions.After troubleshooting and training, the customer no longer experienced this issue.

Manufacturer Narrative

Previously reported b.6: two data files were provided by the customer and reviewed by thermo fisher scientific.The amplification curves in both data files showed evidence of optical mixing caused by inadequate vortexing.Of the 140 clinical sample wells analyzed, thermo fisher was able to confirm 20 false positive sample wells.This information was communicated to the customer.Corrected b.6 data: two data files were provided by the customer and reviewed by thermo fisher scientific.The amplification curves in both data files showed evidence of optical mixing caused by inadequate vortexing.Of the 188 clinical sample wells analyzed on the two files, thermo fisher was able to confirm 21 false positive sample wells.This information was communicated to the customer.

• 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
• MDR Report Key: 10457574
• MDR Text Key: 227624920
• Report Number: 3009976420-2020-00010
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A47814
• Patient Sequence Number: 1