MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 ANTIGEN SELF TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problem Burning Sensation (2146)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: the investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The user reported swabbing both nostrils with the reagent.The user put six (6) drops of reageant on the binaxnow covid-19 antigen self test kitted swab then swabbed both nostrils.No serious injury reported.The patient did not receive and medical treatment.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Please see updates: d4, g3, g6, h2, h4 and h6.G4 correction: eua(b)(4).Technical service provided the safety data sheet to the customer and no further action is required.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13031224
• MDR Text Key: 282839075
• Report Number: 1221359-2021-03826
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 158725
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female