MAUDE Adverse Event Report: IHEALTH LABS, INC. COVID RAPID ANTIGEN TEST KIT AT HOME; 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 01/29/2022

Event Type  malfunction  

Event Description

Tested for covid using ihealth home test kit given out by (b)(6) while experiencing severe symptoms of flu like symptoms.Result came negative.Next day did rtpcr test that came positive.Used the home test kit again to verify reliability.False negative again.Inadvertently exposed many people to covid due to false negative.Poor quality unreliable product.Test kit supplied by (b)(6).Imported from (b)(6).Gin (b)(4) lot no.(10): 213c021224 -06 use by(17): 2022-06-23.Fda safety report id # (b)(4).

• Brand Name: COVID RAPID ANTIGEN TEST KIT AT HOME
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): IHEALTH LABS, INC.; 120 san lucar ct.; sunnyvale CA 94086
• MDR Report Key: 13426298
• MDR Text Key: 285223623
• Report Number: MW5107161
• Device Sequence Number: 2
• 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: 01/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, Black Or African American, White, American Indian Or Alaskan Native, Native Hawaiian Or Other Pacific Islander