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

Catalog Number 195-000

Device Problem False Negative Result (1225)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

The customer reported one hundred ninety-one (191) false negative results with the binaxnow covid-19 ag card occurring in the month of (b)(6) 2022 performed on multiple patients.This mfr.Report addresses result one hundred seventy (170) of one hundred ninety-one (191) and lot number 186389 (quantity 21) the patient tested negative with the binaxnow covid-19 ag card on a nasal swab sample on (b)(6) 2022.Confirmation testing was performed within 48 hours molecular testing (pcr or lamp) using a sample obtained at the same site on the same day and generated positive results.The patient was reported to have been asymptomatic at the time of testing and not known to be covid-19 positive at the time of testing.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.Per the customer no additional information will be provided on the false negative results or individuals tested.Per the customer, routine testing was being performed at community organizations (non k-12 schools, non long term care facilities) and the ag cards have been functioning as expected.The customer did not allege a malfunction of the device and confirmed this is routine reporting per the binaxnow covid-19 ag card instructions for use (ifu).

Manufacturer Narrative

Additional information: patient identifier: (b)(6).Investigation summary: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 186389 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 kit part number 195-000 / lot 186389 and device part number 195-430h/ lot 182878.The lot met the required release specifications.(b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient samples.Reference related mfr.Report numbers: 1221359-2022-04568 through 1221359-2022-04758.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: 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: 15583195
• MDR Text Key: 306265758
• Report Number: 1221359-2022-04737
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901723010510186389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: 195-000
• Device Lot Number: 186389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female