MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS QUICKVUE AT-HOME OTC COVID-19 TEST

Catalog Number	20402
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported two false positive sars results.The consumer communicated the results were confirmed by another rapid antigen assay.This is report 2 of 2.
Additional Manufacturer Narrative
Investigation conclusion: manufacturing records were reviewed for this lot.All release criteria were met.Additionally, no significant trends for the reported issue for this lot were identified in the complaint history log.Root cause: unable to determine source: phone.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Common Device Name: QUICKVUE AT-HOME OTC COVID-19 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: 21131534
• Report Number: 0002024674-2025-00104
• Device Sequence Number: 18021790
• Product Code: QKP
• UDI-Device Identifier: 30014613339724
• UDI-Public: (01)30014613339724(17)250921(10)000248
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210269
• 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): 01/10/2025

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: 09/21/2025
• Device Catalogue Number: 20402
• Device Lot Number: 000248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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