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

Catalog Number 195160

Device Problem Improper Chemical Reaction (2952)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/14/2021

Event Type  Injury  

Event Description

The user reported an allergic reaction with the binaxnow¿ covid-19 antigen self test performed (b)(6) 2021.The user reported that after 3 hours of doing the test, he started to experience a runny nose and a headache which lasted the whole night of (b)(6) and the whole day the next day.The user took a nasal saline wash to stop it.The user refused to call a doctor.No medical treatment was provided.

Manufacturer Narrative

Technical service advised the user to seek medical care and provided them with the customer with the sds for the nasal swabs.The investigation is still in progress.A supplemental report will be provided after completion.

Manufacturer Narrative

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

This supplemental report is being submitted to provide corrected data.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 13007142
• MDR Text Key: 282839677
• Report Number: 1221359-2021-03728
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722030710160341
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Catalogue Number: 195160
• Device Lot Number: 160341
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 04/21/2022; 12/05/2022
• Supplement Dates FDA Received: 05/10/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White