MAUDE Adverse Event Report: COVID 19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

Re: covid molecular test administered at (b)(6) on (b)(6) 2020.This is on behalf of my daughter.My husband is a molecular chemist who worked on developing the tests for a major pharmaceutical firm.Here is how the testing was handled at this site.Test swab was not administered by technician.It was handed to my daughter to swab herself.She was then instructed to dip the swab into the fluid in the tube and seal it rather than breaking it off and leaving it in the tube.Test was deposited into a metal "mail box" type receptacle, outside on an 82 degree day (temperature control inadequate.) her symptoms have worsened over the course of the week and she was just directed by her physician to complete another test; (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID 19 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 10442125
• MDR Text Key: 204206262
• Report Number: MW5096189
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 95