MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195000

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported accidentally putting binaxnow covid-19 reagent in his eye instead of his eye drops.The customer reported he flushed his eyes with water and has been to his primary care doctor which also flushed his eyes.The customer is still feeling slight burning and itchiness in his eyes.The customer was also visited the ophthalmologist eye doctor.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion.Technical service provided the safety data sheet to the customer and no further action is required.Based on the information provided, the investigation is deemed complete.The product will continue to be monitored and tracked.

• Brand Name: BINAX NOW COVID-19 AG CARD
• 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12346292
• MDR Text Key: 267439099
• Report Number: 1221359-2021-02315
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• 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: 04/25/2022

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: 195000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic