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

Catalog Number 195-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported an adverse reaction to the product swab with the binaxnow covid-19 antigen self test.Per the customer, the customer was experiencing multiple symptoms over a time period.Additionally, the customer stated this from repeat exposure to the binaxnow covid-19 ag card.The first two weeks were okay.Starting on the third week, immediately after testing, there was a burning sensation followed by numbness where the swab contacted the nose.The numbness faded within a few hours.The customer also stated that the problems are getting more pronounced with each exposure.This was reported to fda in medwatch report mw5104435.Although requested, additional information, including patient treatment and outcome was not provided.

Manufacturer Narrative

Investigation report: the manufacturing records and quality control release testing was reviewed for kit part number 195-000/ lot 154369 and device part number 195-430h/ lot 146669a.Quality control release testing met specifications.The manufacturing batch records were also reviewed for swab component part number pk002720/ lot 2021020071 and lot 2021020033 and were found to meet release specifications.The information to enable further investigation was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend/unexpected performance at the lot and product family level.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.

Manufacturer Narrative

The supplemental report is being submitted to correct the previously reported event and provide additional information.H6: medical device problem code was missing in initial report.2993 has been added.H6: health effect - clinical code updated from 4582 to 2146.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: elissa zavorotny ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12838086
• MDR Text Key: 281002667
• Report Number: 1221359-2021-03493
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721110810154369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 195-000
• Device Lot Number: 154369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2022
• 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
• Patient Weight: 70 KG
• Patient Race: White