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

Device Problem False Negative Result (1225)

Patient Problems Viral Infection (2248); Loss of consciousness (2418)

Event Date 12/15/2021

Event Type  Death  

Event Description

On (b)(6) 2021 myself and my son went to fcts rapid and pcr covid testing site in (b)(6).We both were tested.Both of our rapid tests were positive.On (b)(6), my son was taken by ambulance to (b)(6) hospital in (b)(6).He was nonresponsive.On (b)(6), life support was stopped, he died.He was only (b)(6) years old.We had both gotten emails with the pcr test results.Both of our tests were negative.I believe that the testing site is having many false positives and false negatives.I also believe that this site should be investigated.Fda safety report id# (b)(4).

• Brand Name: COVID 19 PCR TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 13306904
• MDR Text Key: 284189498
• Report Number: MW5106807
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White