MAUDE Adverse Event Report: QUIDEL CORP. QUICKVUE COVID TEST PI ONLINE WITH FDA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Using the quickvue rapid at home covid test.Followed directions online, gfs.There is a typo in the negative test results section! typo is 'note'.Should say not detected; (b)(4).

• Brand Name: QUICKVUE COVID TEST PI ONLINE WITH FDA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 12779240
• MDR Text Key: 280590673
• Report Number: MW5105166
• 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: Patient
• Type of Report: Initial
• Report Date: 11/03/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2021
• Patient Sequence Number: 1