MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

We have investigated this incident to better understand facts/circumstances and to identify root causes of this event.See below for the investigations and results.1.Review of previous customer complaints a.Breakage of swab inside of nostril was a first incident reported out of millions of tests distributed.In the light of numbers of test distributed and used by intended users, this appears to be isolated event which is likely caused by user error.2.In-house clinical studies a.Hundreds of our tests are being tested by access bio employees every week to monitor covid-19 infection status and such breakage of swabs were never reported.3.Communication with vendor a.Flexibility of the reported lot of nasal swabs (#89432) was tested and passed the test by a vendor.Such breakage inside of nostril was also first incident reported to the vendor.4.Communication with the complainant a.The complainant noted via phone call that her child was a bit resistant when she was trying to collect sample from her child.This indicates that there might be extensive forces applied to nasal swabs that might lead to breakage of swabs inside nostril.The nasal swabs is suitable for sample collection in the intended nasal area and for short contact.It is not intended to be used in conditions that require the ability to resist deformation.The said investigations demonstrated that this breakage of nasal swab inside nostril might be caused by a user error.Access bio will continue to monitor future complaints through our data trending programs and take further actions based on identified valid trends.

Event Description

On may 9 2022, access bio received a complaint via email regarding the incident that a portion of swab was broken during sample collection inside the nostril of a child and stuck in his nose, requiring the complainant to visit an ent to remove the portion from child's nose.The swab was stuck in his nose for about 5 hours and it irritated the child but the child did not have severe pain or issue in breathing according to his mother.The portion was removed successfully on the same day.

• Brand Name: ON/GO COVID-19 ANTIGEN SELF-TEST
• Type of Device: COVID-19 ANTIGEN SELF-TEST
• Manufacturer (Section D): ACCESS BIO INCORPORATE; 65 clyde rd suite a; somerset NJ 08873
• Manufacturer Contact: david park ; 65 clyde rd suite a; somerset, NJ 08873 ; 7328734040
• MDR Report Key: 14711690
• MDR Text Key: 295904104
• Report Number: 3003966368-2022-00134
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RCPM-00279
• Device Lot Number: CP21L59
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Male