MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195-100

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

Patient Problem Epistaxis (4458)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported a nosebleed after swabbing after swabbing it to perform the binaxnow covid-19 home test.Per the customer, additional information will not be provided.

Manufacturer Narrative

Additional information; investigation.The reported false result due to (blood / mucus) on swab is anticipated in nature and severity for binaxnow covid-19 home test.

Manufacturer Narrative

This supplemental report is being submitted to provide corrected data.

Manufacturer Narrative

This supplemental report is being submitted to provide corrected data.

• Brand Name: BINAXNOW COVID-19 HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12006454
• MDR Text Key: 256687452
• Report Number: 1221359-2021-01420
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721090110136103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203107
• 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: 12/23/2022

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: 09/01/2022
• Device Catalogue Number: 195-100
• Device Lot Number: 136103
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 07/28/2021; 12/05/2022; 12/23/2022
• Supplement Dates FDA Received: 08/27/2021; 12/05/2022; 12/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2020
• 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