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 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Instrument data log files were reviewed by thermo fisher scientific.7500-series instrument: patient well gives a false positive call (1) due to inadequate centrifugation (trapped air bubble).Quant studio 12k instrument (off-label): files show late ms2 amplification, likely due to ms2 reagent handling and bubbles due to inadequate centriguration.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer, concluded 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 and provided training materials.

Event Description

Customer submitted 4 data files with several samples that did not appear to amplify (viral targets or ms2 control).Most were called as na by the interpretive software v1.2.However, there were a few samples that reported potentially false calls.Thermo fisher scientific's investigation of the patient results, run results, and additional data from the customer, concluded 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 and provided training materials.After troubleshooting, the customer agreed to re-run the impacted assay plates; no potentially false results were reported to patients or their healthcare providers.The customer reported no patient deaths or serious injuries to thermo fisher scientific.

• 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: 10451891
• MDR Text Key: 248929170
• Report Number: 3009976420-2020-00005
• 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: 08/10/2020

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: 05/06/2020
• 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