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

Catalog Number RCPM-00279

Device Problem False Negative Result (1225)

Patient Problems Fever (1858); Viral Infection (2248)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

I tested myself twice on the same day having strong symptoms of covid including having a fever.I know i did the test right and it showed negative both times.I knew something wasn't right, so i went to urgent care on the same day, and they tested me, and i was positive for covid., so this is telling me your on/go test was defective.

Manufacturer Narrative

1.Review of device history record (dhr) of cp21k43: dhr of the product was reviewed to examine any deviations during the production.The records demonstrated that the lot was manufactured in accordance with approved standard operating procedures.2.Review of in-process quality control performance of cp21k43 test record: a total of 800 cassettes were tested against qc panels and all cassettes showed valid results.3.Retain test of cp21k43: a total of 5 kit boxes (10 cassettes) were tested against qc panels and showed valid results.Additional 5 kit boxes (10 cassettes) were tested at access bio by individuals having no clinical signs, symptoms, conditions.All 10 cassettes showed valid negative results.

Manufacturer Narrative

Possible root causes of suspected false negative results reported by the complainant are following: 1.Complainant might misinterpret test results.2.Complainant might not follow the instructions for use (ifu).A.Inadequate sample collection.B.Inadequate sample elution.C.Interpreting results before 10 minutes.D.Not performing test immediately after opening the test device in the pouch.E.Potential contact with foreign substances and household cleaning products during sample collection and testing.F.Operating test outside of storage conditions.G.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.Test complainant performed might yield false positive result.After several attempts via email and phone, we finally connected with his wife on (b)(6)2022.His wife agreed to ask her husband to response to our questions within a week.Once we have a response from the complainant we will be able to rule out some of potential root causes identified above.An update will be submitted via a follow-up report.

• 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: 13536966
• MDR Text Key: 287206876
• Report Number: 3003966368-2022-00002
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: RCPM-00279
• Device Lot Number: CP21K43
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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 Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 64 KG