MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT-HOME OTC COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 1465001 QV SARS

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

This covid at-home test that the government sent out is an irresponsible product.There are streaks of pink that come up on any test strip used, causing confusion and panic around if the person taking the test is covid-positive or not.I took one test two days ago and had the faint pink streak, which then sent me into a period of isolation and panic due to fear of having covid.I took another brand's test and was definitively negative.Now i am in a period of serial testing for days on end due to this nonsense.I took the second test in the quickvue pack and, yet again, a super faint line that makes it impossible to know for certain if the test is negative or positive.This product is irresponsible and should not be distributed.Binax was far superior, as are other brands.

• Brand Name: QUICKVUE AT-HOME OTC COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16363199
• MDR Text Key: 309479014
• Report Number: MW5114869
• Device Sequence Number: 2
• 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: 02/08/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/22/2023
• Device Model Number: 1465001 QV SARS
• Device Lot Number: 003212
• Patient Sequence Number: 1