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 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the package insert (pi) was conducted for clarity of instructions.No issues were found.The customer's reported problem was related to a deviation from the instructions called out in the pi.Root cause: customer procedural error.Source: phone.

Event Description

Customer reporting seeing a positive line form on two different tests after the recommended read time of the test (outside of product insert specifications for read time).Customer was informed that the test should be read within stated read time found in product insert and once outside that timeframe the test is not valid.Report 2 of 2.

• 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: 19041872
• MDR Text Key: 339675560
• Report Number: 0002024674-2024-00216
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 20452
• Device Lot Number: F42153
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• 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