MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported three false positive results with the binaxnow covid-19 ag card performed on (b)(6)2024.This mfr.Report addresses test three (3) of three (3).Confirmation pcr (platform - unknown) testing was performed on (b)(6)2024 which generated a negative result.The customer stated the patient was asymptomatic and was not on any treatment for covid.Patients were transferred to a quarantine area due to false positive result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
Additional Manufacturer Narrative
D4 udi: (b)(4).The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use, device discarded.
Event or Problem Description
The customer reported three false positive results with the binaxnow covid-19 ag card performed on (b)(6) 2024.This mfr.Report addresses test three (3) of three (3).Confirmation pcr (platform - unknown) testing was performed on (b)(6) 2024 which generated a negative result.The customer stated the patient was asymptomatic and was not on any treatment for covid.Patients were transferred to a quarantine area due to false positive result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
Additional Manufacturer Narrative
D4 udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227687y with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-000/ lot 227687y, test base part number 195-430h/ lot 223637.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 227687y showed that the complaint rate is (b)(4).The binaxnow covid-19 ag card customer return kit lot 227687y was tested using the returned kit components including devices, extraction reagent, blank patient swabs, and in-house covid-19 lod positive control.All tests were run in triplicate, were valid, and performed as expected.No false positive results were observed, and the customer's complaint was not replicated.Abbott diagnostics scarborough was unable to determine the exact root cause of the false results; however, they could possibly be related to self-test user performance or the specific patient sample.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 18956312
• Report Number: 1221359-2024-00297
• Device Sequence Number: 9364411
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA202537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2024
• Device Catalogue Number: 195-000
• Device Lot Number: 227687Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown