MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

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

Patient Problem Insufficient Information (4580)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use, device discarded.

Event Description

The consumer reported a little amount of blood on the swab using binaxnow covid-19 self-test performed on an (b)(6) 2023.The consumer indicated that medical intervention was taken; however, the consumer refused to provide any details.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplement report will be provided after completion.The lot number initially provided was found to be invalid and has been updated accordingly in d4.H3 other text : single use, device discarded.

Event Description

The consumer reported a little amount of blood on the swab using binaxnow covid-19 self-test performed on an (b)(6) 2023.The consumer indicated that medical intervention was taken; however, the consumer refused to provide any details.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Updated data: d4: expiration date.Technical services confirmed with the customer that there was no heavy bleeding from the nose, and that the swab was not completely soaked in blood.The customer stated it was a little amount of blood on the swab.The customer stated that they did take medical action to address the bleeding but did not specify what medical actions were taken.Technical services completed at least 3 due diligence attempts to obtain additional information but were unable to reach the customer.No additional investigation is necessary as a product deficiency was not identified.Based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.H3 other text : single use, device discarded.

Event Description

The consumer reported a little amount of blood on the swab using binaxnow covid-19 self-test performed on an (b)(6) 2023.The consumer indicated that medical intervention was taken; however, the consumer refused to provide any details.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• 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 ; 6613888803
• MDR Report Key: 16276725
• MDR Text Key: 308528795
• Report Number: 1221359-2023-00191
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• 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
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 292528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2023
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG