MAUDE Adverse Event Report: QUIDELORTHO CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST

Catalog Number 20398

Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: in response to your complaint, we performed a review of the package insert (pi) for clarity of instructions.No issues were found.The reported problem we believe is related to a deviation from the instructions called out in the pi.Expired product used.Root cause: expired product ust source: phone.

Event Description

Customer reporting testing confirmed positive for sars by both qv otc and another brand rapid antigen test.Customer was prescribed paxlovid and took it for 5 days.Customer states that it has been 2 weeks and is positive by qv otc but negative by another brand rapid antigen.No confirmation testing has been performed.Through interview it was found the customer was using an expired kit.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: QUICKVUE AT-HOME OTC COVID-19 TEST
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 18052048
• MDR Text Key: 327159621
• Report Number: 0002024674-2023-01831
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339670
• UDI-Public: 30014613339670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20398
• Device Lot Number: F41725
• Date Manufacturer Received: 10/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1