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

Catalog Number 20402

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Customer reporting what they feel are 2 false negative sars results.No conflicting or confirmation testing exists, the customer just feels they should be positive based on their symptoms.Further contact with the customer is not possible to gather more information.Report 2 of 2.

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: online review.

• 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: 18849658
• MDR Text Key: 337745358
• Report Number: 0002024674-2024-00183
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 02/27/2024
• 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