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

Lot Number CP21K09

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

I purchased 5 boxes of intrivo's ongo covid test kit for a trip i took last week.Upon arrival when i opened the first box i found the protective film tray missing.All the contents were shaking around in the box.The other 4 boxes were the same.I discovered there were missing pieces including swabs and drip top lids for the specimen collection vials.I had no choice but to use what i could out of the collection.There are no covid tests available to the public for purchase in any store where i was so i had to use these tests and hope they were not contaminated.The manufacturing stamp on 2 of 5 boxes indicate they came from lot cp21k01 and 3 of 5 boxes came from lot cp21k09.One of the test strips from lot cp21k09 was packaged without silica.Every other test strip package i have opened contained one so i'm inferring it was mistakenly left out.Fda safety report id# (b)(4).

• 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: 13314583
• MDR Text Key: 284315194
• Report Number: MW5106837
• Device Sequence Number: 4
• 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: 01/18/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/01/2022
• Device Lot Number: CP21K09
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic