MAUDE Adverse Event Report: LUCIRA HEALTH CHECK IT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Lot Number K08A110804223M2

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/18/2022

Event Type  malfunction  

Event Description

The sample vial seal did not peel open as instructed by the instructions for use.The sample vial has a peelable foil seal with a peel tab.The peel tab removed without peeling the foil from the top of the tube.Lucira check it covid-19 test.Test kit #: (b)(4).Fda safety report id# (b)(4).

Event Description

Additional information received for report mw5112184 on 9/29/2022 for procode qjr.

• Brand Name: CHECK IT
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): LUCIRA HEALTH; 1412 62nd street; emeryville CA 94608
• MDR Report Key: 15462415
• MDR Text Key: 300440513
• Report Number: MW5112184
• Device Sequence Number: 1
• Product Code: QJR
• 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,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2023
• Device Lot Number: K08A110804223M2
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male