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

Lot Number 197622

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

Received free gov binax now tests in mail.One box of tests does not include the covid-19 test cards only the swabs and reagent bottles.How do i get complete test to replace the incomplete test? incomplete test kit--no test cards.

• Brand Name: BINAX NOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 18419100
• MDR Text Key: 331639529
• Report Number: MW5149664
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/27/2023

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 Lot Number: 197622
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Patient Sequence Number: 1
• Treatment: NEBULIZER
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White