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

Model Number 20452

Device Problem No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2023

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the reported problem is related to a deviation by the consumer from the instructions that are provided in the instructions for use.Root cause: consumer did not follow instructions as provided.Source: direct contact by phone.

Event Description

Consumer reported that they used the test strips to swab their nose.Consumer did not experience irritation or any side effects and were advised to seek medical advice if any irritation occurs.

• Brand Name: CVS HEALTH AT HOME COVID-19 TEST KIT
• Type of Device: CVS HEALTH AT HOME COVID-19 TEST KIT
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 18480442
• MDR Text Key: 332490436
• Report Number: 0002024674-2023-02050
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 20452
• Device Catalogue Number: 20452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1