MAUDE Adverse Event Report: MAXIMBIO / MAXIM BIOMEDICAL, INC. MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 221298

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

I received numerous covid-19 at-home test kits from usps (thank you for supplying tests as a public health measure!) from maximbio.Unfortunately, all of their tests do not work; the control line does not even appear.I have used many tests.I have a phd.I am using them according to their directions correctly.They do not work.

• Brand Name: MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIMBIO / MAXIM BIOMEDICAL, INC.
• MDR Report Key: 15760298
• MDR Text Key: 303404771
• Report Number: MW5113166
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/30/2022
• Device Lot Number: 221298
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White