MAUDE Adverse Event Report: IHEALTH / ANDON MEDICAL CO., LTD. COVID-19 HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 223CO20121

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

The ihealth covid-19 test did not have a control stripe.The results area remained completely white.It's ridiculous that the expiration date is so soon after the order date.(b)(4), lot no: (10)223co20121 use by (17): 2022-07-20.There should be a better distribution system given how hot it is in (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH / ANDON MEDICAL CO., LTD.
• MDR Report Key: 15027613
• MDR Text Key: 296078676
• Report Number: MW5110870
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2022
• Device Lot Number: 223CO20121
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American