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

Lot Number 192468

Device Problems Labelling, Instructions for Use or Training Problem (1318); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2022

Event Type  Injury  

Event Description

While performing the binaxnow covid test, which i had done previously with another product without difficulty, the end of the testing stick came off deep in my nose.I had to go to the emergency room to have this removed.Also, the kit came with 2 sets of directions in spanish, none in english.Some instructions were found online yet kept referring to the information included with the kit.Lot#:192468 ref: 195-160, exp 06-01-2023.Date of use: (b)(6) 2022.Suspected covid.

• Brand Name: BINAXNOW COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 14945571
• MDR Text Key: 295496808
• Report Number: MW5110699
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2023
• Device Lot Number: 192468
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: FUROSEMIDE; METOPROLOL ; MULTIVITAMIN; POTASSIUM; TOPIRAMATE ; VITAMIN D; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White