MAUDE Adverse Event Report: IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 223CO20207

Device Problem Nonstandard Device (1420)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Ihealth covid-19 antigen rapid test/ self-test at home results in 15 mins, lot no.(10): 223co20207 use by (17): 2022-08-06 , the expiration date does not say the self-life is extended.The hospital gave expired self-test at home to the employees of (b)(6).Surge in positive covid-19 cases and rising coronavirus levels and inside the hospital.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC.
• MDR Report Key: 16042351
• MDR Text Key: 306089908
• Report Number: MW5113928
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: 20856362005894
• 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: 12/06/2022

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
• Device Expiration Date: 06/08/2022
• Device Lot Number: 223CO20207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other