MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number LB195160T

Device Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

The binaxnow covid-19 self test made by abbott was very difficult to use in comparison to other self tests, and i couldn't really trust that my negative result was really negative.The first step was to open a little vial of liquid by breaking the top off.I then had to put exactly 6 drops of the liquid into a small hole in a cardboard test card.Some of the liquid got on the cardboard around the hole because the vial was awkward to use.The instructions results would be invalid if you used more than 6 drops.Next i swabbed my nose and had to push the swab horizontally into a second hole in the card until the top of the swab appeared in the first hole.Really, who approved this test kit? it can't be used with any type of precision.

• Brand Name: BINAX NOW COVID-19 SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 16103094
• MDR Text Key: 306799021
• Report Number: MW5114161
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2023
• Device Model Number: LB195160T
• Device Lot Number: 207794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2023
• Patient Sequence Number: 1
• Patient Age: 71 YR