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 Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

Thermo fisher scientific reviewed and analyzed 1 software data log file provided by the customer and identified 3 false positive calls amongst the 81 patient samples.The root cause was determined to be insufficient mixing and vortexing of the qpcr plate.The following data files contained false positive results: file "covid003.Eds" had 3 false positive calls, 47 inconclusive calls.The positive and negative control passed.The thermo fisher field application scientist assigned to this account re-trained the customer to vortex the plates according to the instructions in the ifu, specifically mixing protocol and vortexing instructions.The customer repeated the run, since then the customer has not reported additional problems.

Event Description

Customer submitted a complaint on 08/07/2020 stating that the results from interpretative software did not match amplification plots in quantstudio 3/5 software indicating potential false positive results.Analysis of the customer's data by thermo fisher scientific's technical and field applications scientist teams revealed systematic issues with optical mixing, due to insufficient vortexing of the qpcr plates.Technical and field applications scientist team requested for customer to repeat the run and was instructed to follow the instructions for use.The customer did not report any deaths or serious injuries to thermo fisher.

• Brand Name: TAQPATH COVID-19 COMBO KIT
• Type of Device: TAQPATH COVID-19 COMBO KIT
• Manufacturer (Section D): LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC); 3175 staley rd; grand island, ny
• 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: 10497202
• MDR Text Key: 217146928
• Report Number: 3009976420-2020-00017
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A47814
• Device Lot Number: 2005120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1