MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS, WALGREENS AT HOME COVID-19 TEST KIT

Catalog Number	20460
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion a review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: insufficient information source: online review.
Event or Problem Description
Customer reporting 2 false negative sars results.Customer states they had a known covid exposure and that both them and their child started developing symptoms.Customer states they both were negative by this test but positive by another brand rapid antigen test (timeframe between testing is unknown and further contact with the customer is not possible).Report 2 of 2.

• Brand Name: WALGREENS AT HOME COVID-19 TEST KIT
• Common Device Name: WALGREENS AT HOME COVID-19 TEST KIT
• 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: 20012456
• Report Number: 0002024674-2024-00370
• Device Sequence Number: 4343662
• Product Code: QKP
• UDI-Device Identifier: 00311917122045
• UDI-Public: 311917122045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203087
• 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): 08/19/2024

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: Health Professional
• Device Catalogue Number: 20460
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/21/2024
• 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