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

Catalog Number	20452
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: a review of the dhr of the qv sars pouch lots manufactured with the reported kit lot shows that the lots met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: unable to determine source: email.
Event or Problem Description
Reports 6 false positive results comparted to other rapid antigen test.Patient symptomatic with sore throat.No apparent adverse event.Report 5 of 6.

• Brand Name: CVS HEALTH AT HOME COVID-19 TEST KIT
• Common Device Name: CVS HEALTH 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: 21143357
• Report Number: 0002024674-2025-00049
• Device Sequence Number: 13093755
• Product Code: QKP
• UDI-Device Identifier: 30014613340188
• UDI-Public: (01)30014613340188(10)3766344(17)251110
• 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): 01/13/2025

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: Lay User/Patient
• Device Expiration Date: 11/10/2025
• Device Catalogue Number: 20452
• Device Lot Number: 3766344
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/13/2025
• 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