MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS QUICKVUE SARS ANTIGEN TEST

Catalog Number	20387
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: a review of the dhr found that the lot met all release criteria.Tested 5x returned devices with negative standard.All devices yielded valid and accurate negative results at the 10 minute result read time.Root cause: could not duplicate with retains.Source: phone.
Event or Problem Description
Reports 21 events of false positive results.No confirmation performed.Unknown if patients were symptomatic or asymptomatic.No apparent adverse event.Report 8 of 21.

• Brand Name: QUICKVUE SARS ANTIGEN TEST
• Common Device Name: QUICKVUE SARS ANTIGEN TEST
• Manufacturer (Section D): QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 21347136
• Report Number: 0002024674-2025-00133
• Device Sequence Number: 7958961
• Product Code: QKP
• UDI-Device Identifier: 30014613339373
• UDI-Public: (01)30014613339373(10)709758(11)240803(17)251109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2025
• Device Catalogue Number: 20387
• Device Lot Number: 709758
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown