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

Lot Number 221CO20127

Device Problems Material Discolored (1170); Unsealed Device Packaging (1444); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

I opened an ihealth covid-19 antigen rapid test (received from usps).The box was sealed but inside the swabs, also sealed, were yellowed and the vials were already mixed (i.E.No plastic pack to open, pour into vial and shake).Not really noticing the difference from other test i had used i put one of the yellowed swabs into my daughters nose.The test was inconclusive - neither the c nor the t line appeared.At that point i got concerned about the dirty yellow swabs so opened a second box of the same test.The swabs looked normal and white and the vials were wrapped in plastic, sealed with a sticker and had a separate package of liquid to put into the vial myself.I called my local hhs who determined that they did not need to test for bioterrorism but that i should enter this form.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.
• MDR Report Key: 15542868
• MDR Text Key: 301260908
• Report Number: MW5112408
• 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: 10/03/2022

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: 07/26/2022
• Device Lot Number: 221CO20127
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White