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

Catalog Number 195160

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

The customer reported she was opening the reagent solution when she accidentally splashed the binaxnow covid-19 reagent in her co-worker's eye.The customer reported that the co-worker had irritation of the eyes but they were able to wash their eyes.No healthcare provider was notified nor was any type of treatment provided.According to the package insert in195000 v1.0: 21.The extraction reagent packaged in this kit contains saline, detergents and preservatives that will inactivate cells and virus particles.Samples eluted in this solution are not suitable for culture.Although the volume is too low to likely cause serious adverse events, due to the ingredients of the reagent and the sensitive nature of the eye, there is moderate risk of serious injury to the eye.Therefore, the incident shall be considered reportable.

Manufacturer Narrative

A product deficiency was not reported or found.The customer was provided with the sds.

Manufacturer Narrative

This supplemental report is being submitted to correct the previously reported lot number from 146409 to 151433.Please see updates: g3, g6 and h2.

Manufacturer Narrative

The supplemental report is being submitted to provide additional information.Additional information: technical services informed the user that the reagent solution contains a harmful chemical and gave them the phone number for poison control, if necessary.Technical services advices the customer to contact a health care provider.Technical services could not send the sds sheet for the reagent to the customer because the customer does not have an email account.According to the package insert in195150c v 3.0 precautions the reagent solution contains a harmful chemical.If the solution contacts the skin or eye, flush with copious amounts of water.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: 12719110
• MDR Text Key: 281434325
• Report Number: 1221359-2021-03351
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722021510151433
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 195160
• Device Lot Number: 151433
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2022
• 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