MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH AT HOME RAPID ANTIGEN COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/22/2022

Event Type  malfunction  

Event Description

Had a probable false positive with the ihealth at home covid test.One person in 4 tested positive.All others continued to test negative for 10 days after as did the person who tested positive in the first place.However all 4 had the same symptoms.How does one person test positive, 3 test negative, but 4 have the same symptoms? fda safety report (b)(4).

• Brand Name: IHEALTH AT HOME RAPID ANTIGEN COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 120 san lucar ct; sunnyvale CA 94086
• MDR Report Key: 13424101
• MDR Text Key: 285072401
• Report Number: MW5107115
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/29/2022

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: 02/01/2022
• Patient Sequence Number: 1
• Treatment: MELATONIN; NASONEX
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White