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

Catalog Number A47814

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

Patient Problem No Information (3190)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Thermo fisher scientific reviewed patient results, run results, and additional data from the customer.Root cause was determined to be: user did not properly vortex and/or centrifuge the qpcr plate according to ifu instructions.

Event Description

Customer is not following approved eua workflow and ifu.A customer reported false positive results when using the taqpath covid-19 combo kit for an off-label use.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.

• 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 ; 6055 sunol boulevard; pleasanton, ca
• MDR Report Key: 10457527
• MDR Text Key: 241681752
• Report Number: 3009976420-2020-00012
• 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
• Type of Report: Initial
• 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 Catalogue Number: A47814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1