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

Lot Number 3649539

Device Problem Shipping Damage or Problem (1570)

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

Event Date 02/06/2022

Event Type  malfunction  

Event Description

(b)(6) sold and shipped quidel quickvue at-home otc covid-19 tests.I order 4 boxes and they arrive with the safety seal broken/open the boxes opened and damaged, and the some of the contents moved.I contacted (b)(6) who refused a refund and failed to have a supervisor contact me; instead the offered 4 replacement boxes.The customer service agent said boxes are shipped from stores and warehouses.The replacement boxes also arrived open-- the safety seal deliberately and intentionally opened, the boxes opened, and the some of contents moved around.The mailing envelope is sealed, but someone at (b)(6) or a (b)(6) is deliberately tampering with the at-home covid-19 tests; they could potentially be reselling used tests.I contacted quidel, the manufacturer, who told me that they have been receiving calls about (b)(6) selling opened covid-19 tests.(b)(6) is either engaging in fraud (selling opened and perhaps damaged/used tests and refusing to refund the cost to the consumer), or is exhibiting gross negligence in sending out opened/damaged medical tests; either way this is illegal and contributes to the spread of covid- 19.I have the boxes, the mailing invoices, and the records form contacting (b)(6) is you would like those.Fda safety report id # (b)(4).

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13499486
• MDR Text Key: 285462262
• Report Number: MW5107298
• Device Sequence Number: 1
• Product Code: QKP
• 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
• Report Date: 02/06/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/23/2023
• Device Lot Number: 3649539
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White