MAUDE Adverse Event Report: QUIDELORTHO CORPORATION QUICKVUE SARS ANTIGEN TEST

Catalog Number 20387

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

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

Event Date 04/02/2024

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: email.

Event Description

Customer reporting what they feel are multiple potential false positive sars results for 1 patient.A symptomatic patient was confirmed positive with sars and treated with paxlovid with this test.Customer then had a negative result with this test one week later.Customer become symptomatic again and tested sars positive (possible re-bound case).Customer is no longer symptomatic but still testing sars positive with this test while other brand rapid antigen tests are negative.No pcr confirmation testing has been completed for this patient.Report 1 of 10.

• Brand Name: QUICKVUE SARS ANTIGEN TEST
• Type of Device: QUICKVUE SARS ANTIGEN 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: 19059517
• MDR Text Key: 339702245
• Report Number: 0002024674-2024-00221
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339373
• UDI-Public: 30014613339373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20387
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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