MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 195-160

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Tried to use a binaxnow covid test but the directions were in spanish.No english directions were available.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 15042918
• MDR Text Key: 296133896
• Report Number: MW5110904
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/20/2023
• Device Model Number: 195-160
• Device Lot Number: 196060
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female