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

Catalog Number A47814

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Customer provided 5 data files on (b)(6) 2020 from 5 runs on the 7500 fast instrument two of the data files contained amplification-like behavior in all s-gene curves for wells otherwise considered negative across the plate.Signal does not appear to be coming from sample.No false positive sample calls were identified.

Event Description

Improper mixing of plates led to erroneous results.Customer found false-positive results reported by the covid interpretive software for the s gene target.Consultation with technical support and field support determined cause was partially related to user error, partially related to abnormal background signal for assay.Test results reporting was delayed.False positive calls for the single viral target rendered the wells inconclusive instead of true negative, requiring re-test.No 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: 10451948
• MDR Text Key: 229088964
• Report Number: 3009976420-2020-00007
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• 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