MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW AG TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 143927

Device Problems Material Discolored (1170); Device Emits Odor (1425)

Patient Problems Sneezing (2251); Caustic/Chemical Burns (2549)

Event Date 09/01/2021

Event Type  Injury  

Event Description

Binaxnow ag test use for covid-19 under emergency use authorization.(eua): binaxnow ag test kit, lot # 143927, expiration date of 09/23/2021.On (b)(6) 2021, individual utilized a swab from the box of test kits indicated to swab herself.At the time that she swabbed herself, she told the nurse that the swab had a "very strong odor".On (b)(6) 2021, individual notified the facility that she had received "chemical burns" in her nostrils, indicating it was from the swab.When asked about the swab, she stated that she noticed it had a "yellow" color to it and had a very strong odor.(the nurse that provided the swab to the individual did not notice a discoloring or odor), individual indicated that she watched the nurse open the packet containing the swab and he did not lay it down anywhere prior to handing it to her.Individual stated that following the swab, she had a large amount of nasal drainage and sneezing.Stated that she went to a medical provider who indicated she has "chemical burns" in her nasal area.Facility had used the full box prior to being notified by this individual.There have been no other negative/adverse reaction reported.(as a matter of fact, we have 12 long term care facilities utilizing these kits and we have had no other negative/adverse reactions at all.).

• Brand Name: BINAX NOW AG TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12438495
• MDR Text Key: 270615263
• Report Number: MW5103742
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/23/2021
• Device Lot Number: 143927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR