MAUDE Adverse Event Report: MEDEK COVID-19 ANTIGEN TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Product Quality Problem (1506); Failure to Obtain Sample (2533); Defective Device (2588); Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2021

Event Type  malfunction  

Event Description

Repeatedly didn't work; i purchased medek covid-19 antigen test kits.Thus far, out of seven used, four were defective.The tests were meticulously complied with.Despite the compliance with instructions, 4 out of seven returned "inconclusive" results.In other words, the tests were defective and failed to produce any viable result because the liquid sample failed to wick through the test strip through to the end of the paper where the result was reported.Per instructions, this means the kit result is a total failure and must be discarded as defective; a new kit opened and used.This is a failure rate of over 57%.With each kit sold at (b)(6), this is an unacceptable consumer product standard, and is not "safe and effective." one can expect one kit out of a hundred to fail.But 57% when the problem was reported to the company in an email, the company ignored the report and did not respond.Fda safety report id# (b)(4).

• Brand Name: MEDEK COVID-19 ANTIGEN TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 11444357
• MDR Text Key: 238874902
• Report Number: MW5099842
• Device Sequence Number: 4
• Product Code: QKP
• 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: 03/04/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 70