MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINASNOW COVID-19 ANTIGEN SELF-TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 186406

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2022

Event Type  malfunction  

Event Description

In today's mail, i received my additional government-secured, free binaxnow covid-19 test kits.The contents of both two packages are rattling in the box, unsecured.This was not the case with the original government-secured test kits.I believe the two received today should be discarded.(i do want a response to this complaint, please).The chance that these test kits are broken or otherwise negatively impacted, are great.False results are frequent enough without this.Now, i will be without the two tests.While this form will offer areas for lot numbers, i included them here - and, please note that i have no devices that read the icons on the packaging: 195160 2023-05-04, lot 186406, (b)(4); the upc code on both kits is: 8 11877 01140 8.Fda safety report id# (b)(4).

• Brand Name: BINASNOW COVID-19 ANTIGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 13861989
• MDR Text Key: 287798928
• Report Number: MW5108406
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 811877011408
• 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: 03/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/04/2023
• Device Lot Number: 186406
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female