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

Catalog Number 20402

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

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

Event Date 02/25/2024

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.The company makes no claims for the functionality of products beyond their expiration date.Root cause: unable to determine / possible expired product use.Source: phone.

Event Description

Customer reporting 2 potential false positive sars result.No conflicting test result occurred and no confirmation testing was performed.The customer feels they should be negative because they are asymptomatic.Through interview it was found the customer was using an expired kit.Report 2 of 2.

• 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: 18976195
• MDR Text Key: 338611937
• Report Number: 0002024674-2024-00210
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339724
• UDI-Public: 30014613339724
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20402
• Device Lot Number: F40894
• Date Manufacturer Received: 02/28/2024
• 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