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

Catalog Number	20460
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported two false negative sars results.The consumer communicated the results were confirmed by an alternate testing method (method unknown).This is report 2 of 2.
Additional Manufacturer Narrative
Investigation conclusion: a review of similar complaints of the reported problem for this product was completed and no adverse trends were identified.Without product lot information, no further testing could be conducted.Root cause: insufficient information.Source: online customer reviews.

• Brand Name: WALGREENS AT-HOME OTC COVID-19 TEST
• Common Device Name: WALGREENS 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 92121
• MDR Report Key: 20239612
• Report Number: 0002024674-2024-00477
• Device Sequence Number: 15681632
• 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: EUA210269/S4
• 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): 09/17/2024

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: 20460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/17/2024
• 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