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

Model Number 0036006191665

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

The on/go covid-19 antigen self tests are faulty.I took several 2 weeks ago and they all came back negative, however i was and still is positive for covid-19.I ordered more of the same test as well as another brand and had a lab test done and the only negative test was this on/go brand distributed by intrivo manufactured by accessbio lot # cp22a55.There was an email sent out stating that even though the expiration date is expired that the fda had approved extending the expiration date.I believe this company is selling faulty covid tests, this can be incredibly dangerous.

• Brand Name: ON/GO COVID-19 ANTIGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 16042344
• MDR Text Key: 306182129
• Report Number: MW5113927
• 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: 12/06/2022

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 Expiration Date: 03/31/2023
• Device Model Number: 0036006191665
• Device Catalogue Number: 092022
• Device Lot Number: CP22A55
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White