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

Catalog Number 195160

Device Problem Use of Device Problem (1670)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a suspected allergic reaction with the binaxnow¿ covid-19 antigen self test swap on (b)(6) 2021.The customer reported that the swab was burning her nostril.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplemental report is being submitted to correct the previously reported event of a conflicting result.Correction to previous reported details are as follows: the consumer reported that they flushed their nose with water and the burning subsided after 2.5 hours, but it still feels sore and mucus is still pooling in the back of my throat.The consumer reported that the inside of the nose was burned by the swab and the consumer has a known allergy to plastics and nylon was not aware the swab was nylon.No further testing was performed, the consumer's nose was just looked at by doctor and reportedly, the inside of the nose was burned by contact with the swab.No treatment or medication was administered, and the consumer's nose healed on its own.

Manufacturer Narrative

This supplemental report is being submitted to correct pma/510k from eua (b)(4) to eua (b)(4), correct the "life threatening" option was selected in error and provide the investigation conclusion.The customer was unable to provide the required intake information.The information to enable further investigation, such as the kit's lot number, 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.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide corrected data.

• Brand Name: BINAX NOW 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12758771
• MDR Text Key: 280573057
• Report Number: 1221359-2021-03372
• 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,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195160
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White