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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Hello! i am reaching out to report some issues i have found with covid testing recently.I have had three incidents of positive at-home rapid tests followed by negative pcrs: (b)(6) 2022: my 3 yo had a faint positive for one day on binax now, tested negative with pcr that afternoon - assumed false positive on rapid (she was symptomatic) (b)(6) 2022: my 6 yo had 3 days of faint positives on binax now followed by negative pcr on 2nd day - again assumed false positives (she was symptomatic) (b)(6) 2023: my 6 year old tests positive for one day on binax now, faint but obvious.I tested positive two days later and continued to test positive for a total of 7 days - all obvious positives and all binax now.My daughter and i both had pcrs on day 3 of symptoms for her and day 4 of symptoms for me - both negative.By this time i had cancelled school and called off work.Feeling frustrated i got another pcr on day 7, also negative.The (b)(6) 2023 episode i personally had ten positive rapid tests from binax now (two different lot numbers) and daughter had one positive on binax now.Between the two of us we had three negative pcrs.My daughter started testing positive on rapids on day 4 of symptoms and myself day 5.We have used binax now for over a year and have not had a single line until these three incidences listed above.All of our pcrs were been done at cvs in montgomery, ohio.I just wanted to get this information out there.I doubt many people confirm a positive home rapid with a pcr these days.Please let me know if you have any questions, and thank you for your time! (b)(6).Reference reports: mw5116406, mw5116407, mw5116408, mw5116409, mw5116410, mw5116411, mw5116412, mw5116413, mw5116414, mw5116415, mw5116417, and mw5116418.

• Brand Name: BINAXNOW COVID-19 AG
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 16700511
• MDR Text Key: 313067106
• Report Number: MW5116416
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Female