MAUDE Adverse Event Report: COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Patient Problem Viral Infection (2248)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

I work for as a covid compliance manager.This is the 3rd time someone has tested positive, then went to (b)(6) to confirm and the results from (b)(6) came back negative.The past two times this has happened, it turns out they were, in fact, positive.It's too soon to tell regarding the third case that happened today.I don't know if the tests they're using are faulty or if they're not administering them correctly, but it's clearly a pattern.This is the (b)(6).Reference report mw5150803.

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 18594845
• MDR Text Key: 334088765
• Report Number: MW5150804
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: Black Or African American