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

Catalog Number RCPM-00271

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 06/26/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, access bio received complaint via email regarding two (2) false negative results.The complainant said "your test kit produced two false negatives but i tested positive with a pcr test after having symptoms".Access bio followed up two times on june 28, 2022 and july 12, 2022 to better understand facts and circumstances, but there was no response from the complainant.No adverse patient effects were reported.

Manufacturer Narrative

In order to identify the true root cause of this allegation, access bio would need to further communicate with the complainant to rule out potential root causes, however, in the absence of information from the customer it would be difficult to rule out potential root causes identified below.1.Complainant might misinterpret test results.2.Complainant might not follow the instructions for use (ifu) a.Inadequate sample collection.B.Interpreting results before 10 minutes.C.Not performing test immediately after opening the test device in the pouch.D.Potential contact with foreign substances and household cleaning products during sample collection and testing.E.Operating test outside of storage conditions.F.Excessive buffer application to sample well of test device.3.Complainant might not use the test in accordance with its intended use.A.Testing outside of first 7 days of symptom onset.B.Taking high doses of biotin (> 10 mg per day).4.13% of false negative results are expected based on performance characteristics claimed for this test (87% ppa).5.Tests might be exposed to extreme environmental conditions during storage.6.Pcr test that complainant performed might yield false positive result.Access bio will continue to monitor further complaints through our data trending programs and take further actions based on identified valid trends.

• 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: 15123283
• MDR Text Key: 304715605
• Report Number: 3003966368-2022-00135
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: RCPM-00271
• Device Lot Number: CP21L29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2021
• 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 Sex: Male