MAUDE Adverse Event Report: HEALGEN SCIENTIFIC LLC CLINITEST RAPID COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 2203206EUA

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Test is defective.After getting the sample on the swab and putting it in the tube (and doing all the required stirring, sitting and squeezing), i put the dropper top on the tube and made sure it was in all the way.Even with squeezing the tube (which contained the buffer and the nasal swab sample), no drops would come out of the dropper tip onto the cassette testing unit.This brand of test is the only one that i have seen that has a white piece of some material inside the dropper cap.Most of them are open from the bottom to the tip of the dropper.I continued to squeeze the tube to expel the drops into the cassette, and eventually the cap just blew out of the tube, spraying the buffer/sample solution all over the counter.The sample was quite "slimy" when it sprayed over everything, so i don't know if the buffer solution caused this and clogged up this white "plug or filter" inside the dropper cap, or whether the white "plug or filter" was non-porous.This product is under eua, distributed by (b)(4).Package bar code is 00816490025948, lot number 2203206eua, original expiration date of 2023-01, but was extended by us.There is also a ref code on the package gccov-502a-h4us (11561910).

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): HEALGEN SCIENTIFIC LLC
• MDR Report Key: 16876698
• MDR Text Key: 314724169
• Report Number: MW5117247
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2024
• Device Model Number: 2203206EUA
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White