MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 SELF-TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 03/29/2022

Event Type  Injury  

Event Description

The consumer reported that when opening the reagent solution for the binaxnow covid-19 antigen self test on (b)(6) 2022, the consumer may have spilled the solution in his eyes.There was no allergic symptoms nor burning that occurred.The consumer was advised to wash his eyes with water for 15 minutes and consult with a doctor if needed.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.

Manufacturer Narrative

The supplemental report is being submitted to provide the investigation conclusion.A product deficiency was not reported or found.Technical service advised the consumer to contact their health provider if any irritation occurred.Technical services attempted to provide the safety data sheet to the customer but were unsuccessful.A supplemental report will be provided if any additional is obtained.

• Brand Name: BINAXNOW COVID-19 SELF-TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 14186750
• MDR Text Key: 289869881
• Report Number: 1221359-2022-02116
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722061910171138
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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: 171138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2022
• 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 Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White