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

Catalog Number 195-160

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported extraction reagent coming into contact with nose with the binaxnow covid-19 ag self test.Patient had put some binaxnow covid-19 reagent on swab and inserted it up their nose.Customer realized this was incorrect use and wanted to know if this would cause harm.The customer confirmed there was no medical exposures or injuries.

Manufacturer Narrative

Investigation report: a product deficiency was not reported or found.Technical service provided the safety data sheet and advised the consumer to contact their health provider if any irritation occurred.A supplemental report will be provided if any additional is obtained.

Event Description

The consumer reported extraction reagent coming into contact with nose with the binaxnow covid-19 antigen self test.The consumer was informed by a friend that to conduct the test they needed to add binaxnow covid-19 reagent solution to the swab and then insert the swab up their nose.The consumer realized this was incorrect use.The consumer reported that their nose felt numb, but confirmed there was no harm due to the event.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12633350
• MDR Text Key: 276589873
• Report Number: 1221359-2021-03117
• 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: 05/05/2022

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 Catalogue Number: 195-160
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male