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

Catalog Number 95677

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

I am writing to alert you that there is likely a very large number of covid 19 tests manufactured by maxim biomedical, inc.Currently being distributed by the us government that are defective and therefore an immediate threat to the health and safety of those using it and those around them.On (b)(6) 2022, i placed an order for 8 free home covid tests from the us government.The order confirmation numbers were (b)(4) and (b)(4).The tests were apparently mailed from a government distribution facility in (b)(6) on (b)(6) 2022.I received the 8 tests on (b)(6) 2022, which was perfect timing because that was my 5th day of covid isolation.The 8 maxim test kits arrived in two undamaged mailing packages and were in 4 sealed and undamaged maxim test kit boxes.They all had the same ref # 95677, manufacture date 2022-06-30 and lot # mb30jun2201.Prior to receiving the maxim tests, i had used home tests about 10 times in the last two years.I had never before experienced an invalid test result.The maxim tests were noticeably different than prior versions i had used so i carefully read the directions before i opened any test materials and carefully followed the directions when taking the tests.I have now taken seven of the tests in strict accordance with the instructions and all of the tests have come up with "invalid" test results because no lines ever appeared on the test strips.The tests i received were clearly defective and the government should, therefore, immediately cease distributing these tests and commence appropriate quality control testing to see if any of the tests the government still has are suitable for use.It would also appear appropriate for fda to review its use permit for these tests and that the government should look into whether maxim has committed a fraud on the government that has endangered the public.I will hold on to my last presumably defective test kit if some government agency would like to retrieve it as evidence.Fda safety report id# (b)(4).

• Brand Name: CLEARDETECT COVID-19
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIM BIOMEDICAL, INC.
• MDR Report Key: 15275850
• MDR Text Key: 298579308
• Report Number: MW5111631
• 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: 08/19/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2022
• Device Catalogue Number: 95677
• Device Lot Number: MB30JUN2201
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White