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

Catalog Number	20402
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reports false positive tests confirmed with pcr and other rapid test.Unknown number of tests performed.Customer using expired product.Unknown if patients were symptomatic or asymptomatic.Report 2 of 2.
Additional Manufacturer Narrative
Investigation conclusion: a review of the package insert (pi) was conducted for clarity of instructions.No issues were found.The customer's reported problem was related to a deviation from the instructions called out in the pi.Expired product used.Root cause: expired product used.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: 21041597
• Report Number: 0002024674-2024-00679
• Device Sequence Number: 7630849
• Product Code: QKP
• UDI-Device Identifier: 30014613339724
• UDI-Public: (01)30014613339724(10)2208002
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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: Lay User/Patient
• Device Catalogue Number: 20402
• Device Lot Number: 2208002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/30/2024
• 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