MAUDE Adverse Event Report: QUIDEL CORP. QUICK VUE AT HOME OTC COVID 19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 001876

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

I tested for covid at home from a quick vue, quidel test kit i received free from the government.I received 4 boxes and when they arrived several months ago they were left in my mailbox for up to 6 hours in 90 f temperatures before i returned home from work.When i tested the lines according to your standards did not appear correctly and i fear these 4 boxes of tests are ruined.Fda safety report id # (b)(4).

• Brand Name: QUICK VUE AT HOME OTC COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 15042957
• MDR Text Key: 296140215
• Report Number: MW5110906
• Device Sequence Number: 1
• Product Code: QKP
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2023
• Device Lot Number: 001876
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female