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

Catalog Number 195-160

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

The consumer reported via medwatch report, mw5110699, that the tip of the nasal swab from the binaxnow covid-19 antigen self-test came off of the stick deep in their right nostril.The consumer went to the emergency room (er) where a variety of different currettes were used to remove the swab tip.No medication was perscribed; consumer only reported discomfort.The consumer confirmed there was no harm, delay or impact in treatment.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation report: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 192468 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the incoming receipt inspection records and the certificate of compliance was reviewed for component part number pk002545 / lot p0667.The lot met the required release specifications.The incoming receipt inspection records and the certificate of compliance was reviewed for component part number pk002545 / lot p0665 and there were no notes regarding swab defects found.The lot met the required release specifications.The incoming receipt inspection records and the certificate of compliance was reviewed for component part number pk002545 / lot p0625 and there were no notes regarding swab defects found.The lot met the required release specifications.A review of the complaints reported as broken / damaged / defective swab related to kit lot 192468 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance.

• 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 ; 6613888803
• MDR Report Key: 15179662
• MDR Text Key: 303924082
• Report Number: 1221359-2022-03444
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723060110192468
• 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
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 192468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/24/2022
• 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 Age: 72 YR
• Patient Sex: Male