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

Catalog Number 20452

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Customer reporting 1 false negative sars results.Customer states they were symptomatic and the results were sars positive by doctors' office test the next day (method unknown).Further communication with the customer to gather more information is not possible.

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Root cause: insufficient information.Source: online review.

• Brand Name: CVS HEALTH AT HOME COVID-19 TEST KIT
• Type of Device: CVS HEALTH AT HOME COVID-19 TEST KIT
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 18372059
• MDR Text Key: 331094571
• Report Number: 0002024674-2023-02039
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210269/S4
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20452
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• 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