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

Lot Number F41231

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

I received today (b)(6) 2023 4 covid 19 test kits (2 per box) ordered through the gov't usps site.They are expired tests, pre-dating tests on the extended expiration test dates list which i did check.For those to be delivered by the government is ridiculous.Manufacturer quidel quickvue at home test, lot f41231, manufactured 2022-03-25, expiration 2023-03-08.I thought they might still be ok for a few months, but i could not even find this test on the linked extended expiration list.Reference report mw5117979.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 17030689
• MDR Text Key: 316237767
• Report Number: MW5117980
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/08/2023
• Device Lot Number: F41231
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male