MAUDE Adverse Event Report: MAXIM BIOMEDICAL, INC. MAXIMBIO CLEAR DETECT COVID 19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 95677

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2022

Event Type  malfunction  

Event Description

I have used a number of different at home covid tests without any issue.The usg recently shipped out maximbio tests.I followed the instructions to the letter.And got no response.Not a negative.Not a positive.I thought it was an anomaly so i used the second test.Again, no response.There is something wrong with these tests.Fda safety report id# (b)(4).

• Brand Name: MAXIMBIO CLEAR DETECT COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIM BIOMEDICAL, INC.; 1500 east gude drive; ste a; rockville MD 20850
• MDR Report Key: 15282596
• MDR Text Key: 298587369
• Report Number: MW5111658
• 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: 08/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/16/2022
• Device Model Number: 95677
• Device Lot Number: MB27JUNN2201
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White