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

Catalog Number	20398
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reports false positive results over several months.Unknown if symptomatic or asymptomatic.Confirmation not performed.No apparent adverse event.Report 90 of 100.
Additional Manufacturer Narrative
Investigation conclusion: retained devices of the same lot tested with negative standard yielded accurate negative results.Returned product of the same lot from other customers observed faint grey/pink test lines.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: 22937808
• Report Number: 0002024674-2025-00539
• Device Sequence Number: 18611607
• Product Code: QKP
• UDI-Device Identifier: 30014613339670
• UDI-Public: (01)30014613339670(10)709752(11)240801(17)251003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 10/03/2025
• Device Catalogue Number: 20398
• Device Lot Number: 709752
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/02/2025
• 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