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

Device Problem False Positive Result (1227)

Patient Problem Fever (1858)

Event Type  malfunction  

Event Description

Pretty sure i had covid-19 "(b)(6)".I had fever for a couple of days and lost my sense of taste/smell.I got tested a couple of days after i lost the symptoms and tested negative.I got tested a couple more times the following week and all were negative results.Went to (b)(6) to get tested a couple of days ago on the (b)(6) and tested positive (got my results yesterday).I did a couple of rapid tests (yesterday and today) and both were negative results.So i believe my test from (b)(6) was a false positive.Fda safety report id# (b)(4).

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 13343973
• MDR Text Key: 284510944
• Report Number: MW5106949
• 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: Patient
• Type of Report: Initial
• Report Date: 01/20/2022

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: 01/24/2022
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian