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

Catalog Number 195-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

The consumer reported adverse reactions with the binaxnow¿ covid-19 ag card test performed.Patient experienced nasal congestion followed by intense sinus headaches, itching and burning at the point of contact, and numbness in the upper nasal passage, much more uncomfortable than previous adverse reactions to the swab.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 required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• 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 Contact: venkat dakoju ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 12872780
• MDR Text Key: 281998341
• Report Number: 1221359-2021-03566
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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: 195-100
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/13/2022
• 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