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 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Root cause: insufficient information.Source: phone.

Event Description

Customer reporting testing sars false positive more than once (exact number unknown).Customer states they have been negative by other brand rapid antigen tests and pcr.Two reports will be filed for unknown number of results.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: 18493591
• MDR Text Key: 332672039
• Report Number: 0002024674-2024-00080
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20402
• Date Manufacturer Received: 12/20/2023
• 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