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

Catalog Number 195-160

Device Problems Contamination (1120); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation: the investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The user reports inserting the binaxnow covid-19 antigen self test swab into the nose with solution on the swab.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Technical services stated that the reagent solution contains a harmful chemical.If the solution contacts the skin or eye, flush with copious amounts of water.If irritation persists, seek medical advice: the safety data sheet was provided to the customer.An adverse physicochemical, human health and environmental effects review was performed: to our knowledge, this product does not present any particular risk, provided it is handled in accordance with good occupational hygiene and safety practice.The product will continue to be monitored and tracked.

Manufacturer Narrative

This report is being submitted to correct the following fields of the initial report.Please see corrected fields: c, d1, d2, d3, g1, g4, g6 and h2.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough,; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12808057
• MDR Text Key: 281766649
• Report Number: 1221359-2021-03497
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722030810156715A
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 156715A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American