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 09/20/2023

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 information.Source: phone.

Event Description

Consumer advised entire swab tip is saturated with blood after swabbing nostril with too much force.Lot number unavailable, box discarded.Blue control line in test region, no pink line noted.Customer confirmed procedure was followed per pi but did not want to review specifics.

• 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: 18480448
• MDR Text Key: 332490628
• Report Number: 0002024674-2023-02052
• 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: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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