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

Lot Number CP22A53

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

I picked up a covid antigen test from pick n save pharmacy (b)(6) on the evening of (b)(6)2022.The extraction buffer in the kit is precipitated; both vials have crystals of solute in the solution.This would have occurred prior to my purchase as i drove directly home and my car was not freezing.The crystals have remained precipitated and have not redissolved.I have not used either test in the kit but have kept them for now.Lot: cp22a53, exp: sep 2022 (does have sticker noting the expiration extension).Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 11/30/2022 for mw5113537.I can be reached at (b)(6).

• 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: 15893399
• MDR Text Key: 304697755
• Report Number: MW5113537
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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 Lot Number: CP22A53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2022
• Patient Sequence Number: 1