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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Without a lot number, no further investigation can be conducted.Investigation summary: in response to your complaint, we performed a search for similar complaints of the reported problem for this product.No adverse trend was observed for the reported issue.Without product lot information, no further testing could be conducted.Although we were unable to duplicate your complaint, the information you provided has been documented and will continue to be monitored.Root cause: insufficient info.Source: phone.

Event Description

Consumer tested a couple days ago and tested positive.Consumer tested today, got a little bit of blood on swab and inquiring if blood could impact test results.Technical support specialist informed customer that a small volume of blood on test swab would not impact test results, though it may create a pink tinge to the test strip.Consumer inquired about isolation protocols.Tss provided guidance per cdc website.Consumer inquired how long individuals can test positive for covid.Tss informed consumer that can depend on individual immune systems and initial viral load, could be anywhere from 5 days to 2 months.Tss recommended that if symptoms have ended but consumer continues to test positive for a long period of time, they should follow up with hcp for alternative testing.

• 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: 18654875
• MDR Text Key: 334702486
• Report Number: 0002024674-2024-00127
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 12/23/2023
• 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