MAUDE Adverse Event Report: QUIDEL CORPORATION QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Lot Number F40750

Device Problem Component Missing (2306)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

I might have been exposed of covid.I opened one of two free at-home covid tests i received in the mail.The first one did not have the test strips in the box.The other test kit did have them.Fda safety report id# (b)(4).

• Brand Name: QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 14357167
• MDR Text Key: 291497260
• Report Number: MW5109614
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2023
• Device Lot Number: F40750
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White