FDA Adverse Event Malfunction Summary report: N

TAQPATH COVID-19 COMBO KIT

MDR report key: 10457431 · Received August 26, 2020

Report

Report Number: 3009976420-2020-00002
Event Type: Malfunction
Date Received: August 26, 2020
Date of Event: July 15, 2020
Report Date: August 26, 2020
Manufacturer: LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)
Product Code: QJR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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 CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS AND PROVIDED TRAINING MATERIALS.

Description of Event or Problem · 1

UNIVERSITY OF (B)(6) FILED A COMPLAINT WITH THERMO FISHER SCIENTIFIC CONCERNING 5 FALSE POSITIVE PATIENT RESULTS OBTAINED AFTER 1 RUN OF THE TAQPATH COVID-19 COMBO KIT TEST. THESE RESULTS WERE REPORTED TO PATIENTS AND THEIR HEALTHCARE PROVIDERS. THE CUSTOMER RETESTED THE PATIENT SAMPLES USING A DIFFERENT TEST PRIOR TO NOTIFYING THERMO FISHER SCIENTIFIC OF THE FALSE POSITIVE RESULTS. RESULTS FROM THE SECOND TEST SHOWED THAT THE 5 PATIENT SAMPLES WERE NEGATIVE FOR SARS-COV-2. 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 CENTRIFUGE THE QPCR PLATE ACCORDING TO IFU INSTRUCTIONS AND PROVIDED TRAINING MATERIALS. THE CUSTOMER REPORTED NO PATIENT DEATH OR SERIOUS INJURY TO THERMO FISHER SCIENTIFIC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
917333	TAQPATH COVID-19 COMBO KIT	TAQPATH COVID-19 COMBO KIT	QJR	LIFE TECHNOLOGIES CORP (THERMO FISHER SCIENTIFIC)

Patients

Seq	Age	Sex	Outcome	Treatment
1