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 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Root cause: insufficient information (lot number provided by the customer was not a valid lot number - 239528).Source: phone.

Event Description

Customer reporting 4 false negative sars results.Customer states they were positive by another rapid antigen test (timeframe between testing is unknown).Report 4 of 4.

• 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: 18544114
• MDR Text Key: 333258012
• Report Number: 0002024674-2024-00090
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20452
• Date Manufacturer Received: 12/27/2023
• 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