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

Catalog Number 195-000

Device Problem Off-Label Use (1494)

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

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

The labeling of the extraction reagent clearly defines the materials contained within and the package insert refers to the emergency use authorization restrictions set forth.The safety data sheet was provided to the user.No additional information, evaluation or clarification of data is applicable.The reported event is anticipated in nature and severity for binaxnow covid-19 ag card and captured within the product's risk management file.No additional action is necessary.

Event Description

The user reported the accidental use of the binaxnow covid-19 ag extraction reagent instead of the conjunctivitis eyedrop medicine in her baby's eye on (b)(6) 2020.The user stated that her other child administered the binaxnow covid-19 ag reagent to the baby's eye.The user took the baby for an eye exam.The physician performed a litmus test; the ph of the eye was normal.No adverse reaction was observed.The physician did not suggest any treatment for the baby.The baby was reported to be in good health.The user stated that there was no death or serious injury based on the event.Attempts to gain further information were unsuccessful.Due to the reagent ingredients and sensitive nature of the eye, medical opinion determined this event shall be reportable.The user is not a healthcare professional and does not belong to any healthcare/nursing facility.The user reported receiving the test from a family member.Therefore, the customer is not an authorized user of this assay according to the requirements of the package insert.

• Brand Name: BINAXNOW 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 (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alonna pitreau ; 10 southgate road; scarborough, ME 04074 ; 2077305750
• MDR Report Key: 10949866
• MDR Text Key: 220687588
• Report Number: 1221359-2020-00413
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-000
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/04/2020
• 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: 6 MO