MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE AT HOME OTC COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number F41713

Device Problem False Positive Result (1227)

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

Event Date 12/26/2022

Event Type  malfunction  

Event Description

Received a positive quidel quickvue covid test result, lot f41713, exp 07/31/2023.Used correctly and read at proper time.2 other brands of antigen test read negative: binax now and ihealth.Pcr test (abbott id now) negative.This was a false positive result, adding to the many reports of false positives and my own experience as a public health rn where multiple positive results on quickvue are refuted by negative pcr results.

• Brand Name: QUICKVUE AT HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16077349
• MDR Text Key: 306521111
• Report Number: MW5114080
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Lot Number: F41713
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White