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

Catalog Number 20452

Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: unable to determine.Source: phone.

Event Description

Reported discrepant sars result for 1 consumer.It is unknown if the consumer was symptomatic.The consumer communicated that they tested positive with quickvue otc and later negative with another rapid antigen assay the following day.No confirmatory testing had been completed.3 additional consumer events were also communicated which are captured on separate reports.

• 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 ct.; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16620201
• MDR Text Key: 312068934
• Report Number: 0002024674-2023-00941
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• 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: F41943
• Date Manufacturer Received: 03/03/2023
• 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