MAUDE Adverse Event Report: QUIDEL CORPORATION QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 1493200

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 11/19/2022

Event Type  malfunction  

Event Description

Hi, i previously ordered the free at-home covid-19 test kits through https://special.Usps.Com/testkits.I received the quidel quickvue at-home otc covid-19 test brand.Each box comes with two tests.Upon opening and using the first box, it became clear that the liquid reagent the manufacturer supplied was not adequate to conduct a valid test.I opened a second box, combined the available liquid reagent into one tube, and then was able to conduct a valid test.Each of the other boxes i received had the same problem where the test tubes contained half of the necessary reagent.I believe the following information will identify the test kits: for the entire test kit-- ref: 1493200, lot: 801577, expiration: 2024-02-03; for the test strip lot: 154196, exp: 2023-01-30, item: 1465001 qv sars for the swab ref: 1487700, exp: 2024-07-08, lot: 20210708ac looking online at third-party sites like amazon.Com, individuals who purchased the quidel kits also noted insufficient amounts of the liquid reagent.While the tests were free to me, they were provided at taxpayer expense, and so i believe quidel has likely defrauded the government if it promised to deliver two test kits per box when it in effect delivered one test kit per box.Perhaps this is a known issue; submitting my concerns nonetheless.Thank you.Insufficient liquid reagent to perform a valid at-home covid-19 test.Ref mw511519, mw5115120, mw5115121.

• Brand Name: QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16435134
• MDR Text Key: 310264667
• Report Number: MW5115118
• 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: 02/19/2023

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 Expiration Date: 02/03/2024
• Device Model Number: 1493200
• Device Lot Number: 801577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White