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

Lot Number 2203009

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Distress (2329)

Event Type  malfunction  

Event Description

We ordered covid test kits on drs advice.The test kits sent were expired.Past the extended date.I understand kits are sent free, but these need to be within the date which they can be used.I am highly distressed they would send inferior products of such importance.They are unusable and we were asked to test for several days by our medical dr.Quick vue at home lot-2203009,original date 03-15-2022, date of extension 02-28-2023, date received 04-05-2023, 8 tests.

• Brand Name: QUICK VUE AT HOME
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 16700931
• MDR Text Key: 313066938
• Report Number: MW5116427
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2023
• Device Lot Number: 2203009
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1