MAUDE Adverse Event Report: NEST VTM; GENERAL PURPOSE REAGENT

Lot Number 052220MB1

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2020

Event Type  malfunction  

Event Description

I had some contamination in nest 5ml vtm tubes for lot numbers 060620mb1 and 052220mb1.Test name sars-cov-2.

• Brand Name: NEST VTM
• Type of Device: GENERAL PURPOSE REAGENT
• MDR Report Key: 10430671
• MDR Text Key: 203822353
• Report Number: MW5096137
• Device Sequence Number: 2
• Product Code: PPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 052220MB1
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1