MAUDE Adverse Event Report: PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID HOME COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Negative Result (1225)

Patient Problems Viral Infection (2248); Sore Throat (2396)

Event Date 02/18/2023

Event Description

This is not about a vaccination.But this was what was sent to me to file a complaint about the lousy home covid test sent out to medicare patients and others called indicaid, these test do not work.I tested myself with one on (b)(6) 2023.Did it again twice on (b)(6) 2023.Then went to the doc because the sore throat told me i had covid.Sure enough, i tested positive for covid at the doc.Came home and did another lousy indicaid test and showed negative.For the next two days i tested myself with indicaid and they always said negative.I bought my own different home tests and they showed positive.Indicaid is a sham and should not be sent out to anyone.As i have stated, i emailed to complain about the indicaid covid home tests that are mailed out.They emailed me and told me to file this.This has nothing to do with a vaccine.This has to do with a home test that does not work and you are sending these out to people.I am positive for covid.I keep testing and it has yet to show me positive and keeps saying negative.These should not be sent out to anyone.They are not even close to being accurate.Reference reports mw5115746, mw5115748, mw5115749.

• Brand Name: INDICAID HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): PHASE SCIENTIFIC INTERNATIONAL LIMITED
• MDR Report Key: 16546181
• MDR Text Key: 311389415
• Report Number: MW5115747
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White