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

Lot Number 225711

Patient Problem Viral Infection (2248)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Binax now rapid test repeatedly produced negative results several times over a week, in the presence of symptoms.Finally, we went to urgent care, and their rapid test, along with ihealth's in-home rapid test were both positive on wednesday night, 1/3, while binax continued to show negative, including last night, 1/4.Because of the false negatives, patient didn't get proper diagnosis or treatment.Two other tests--one at urgent care and one using another brand of in-home test (ihealth) were positive on the same night.Ref report: mw5150033.

• Brand Name: BINAX NOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.
• MDR Report Key: 18483143
• MDR Text Key: 332617432
• Report Number: MW5150034
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 225711
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female