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 Use of Device Problem (1670)

Patient Problem Eye Pain (4467)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The consumer reported on spilling the reagent on lip eye with binaxnow covid-19 ag self-test on (b)(6) 2023.Per consumer, their eye got irritated.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.Device discarded, single use.

Manufacturer Narrative

Technical services provided the reagent safety data sheet to the customer.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card based on the above summary, the investigation is deemed complete.The product will continue to be monitored and tracked.H1 - type of reportable event h3 other text : device discarded, single use.

Event Description

The consumer reported on spilling the reagent on lip eye with binaxnow covid-19 ag self-test on (b)(6) 2023.Per consumer, their eye got irritated.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: 16486648
• MDR Text Key: 310709349
• Report Number: 1221359-2023-00434
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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 Catalogue Number: 195-160
• Device Lot Number: 220633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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