MAUDE Adverse Event Report: ABBOTT BINAX NOW COVID 19 ANTIGEN CARD; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 387033

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

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

Event Date 04/02/2023

Event Type  Other  

Event Description

Binaxnow covid-19 ag card use for covid-19 under emergency use authorization (eua): patient received a binaxnow covid-19 ag test that was inadvertently run with fluorometholone 0.1% ophthalmic solution rather than test reagent solution (a different patient's medication was not returned to nursing home med cart- likely mistaken for binaxnow reagent bottle when left in testing kit, the bottles look very similar).The invalid but documented result of the antigen test was positive.The error was not identified until the ophthalmic solution was discovered in the test kit and 2 binaxnow tests using the ophthalmic solution in place of reagent were intentionally completed and showed positive results compared to correctly run negative control tests x2.A pcr follow-up test of the patient confirmed that the patient was covid-19 negative via pcr.The patient remained asymptomatic for covid-19 throughout.Negative outcomes for the patient included 6 days of unnecessary transmission-based precautions/isolation and sample collection for the pcr test.Follow up testing after discovery of likely invalid binaxnow covid-19 ag test.Admission to nursing home from hospital, (day 2 after).

• Brand Name: BINAX NOW COVID 19 ANTIGEN CARD
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16796165
• MDR Text Key: 313920570
• Report Number: MW5116920
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/20/2023

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?: No
• Device Lot Number: 387033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Patient Sequence Number: 1
• Treatment: FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP 0.1%, MFR: PACIFIC PHARMA, UID: 60758-880-05
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American