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 Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Sore Throat (2396)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported four false positive sars results.The consumer communicated the results were confirmed by another rapid antigen assay.This is report 4 of 4.
Additional Manufacturer Narrative
Investigation conclusion: a review of the production records found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Patient medication provided by the customer has not been tested by quidel.There is no known impact from this medication on quidel product performance.Root cause: unable to determine.Source: phone.

• 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: 20184173
• Report Number: 0002024674-2024-00473
• Device Sequence Number: 8704143
• 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): 09/10/2024

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
• Device Lot Number: F42163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/10/2024
• 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: Female