MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-000

Device Problem False Negative Result (1225)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 127880 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing batch records and quality control release testing for kit part number 195-000 / lot 127880 and device part number 195-430h / lot 126226a were reviewed.This lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 127880 showed that the complaint rate is (b)(4).Abbott diagnostics (b)(4), inc.Was unable to determine the exact root cause of the reported issue.The available evidence suggests that this device lot is performing within the statements made within package insert related to % test agreement with the expected results by sample concentration.

Manufacturer Narrative

Investigation is not yet complete.Upon completion, abbott diagnostics (b)(4), inc.Will provide a supplemental report.

Event Description

The user reported a false negative result with the binaxnow covid-19 ag test.The user reported a test with the binax now covid-19 ag test performed (b)(6) 2020 generated positive results.However, he had a nose bleed, and blood was on the swab.The test was repeated with a new sample and generated negative results.Confirmation testing with a pcr test (not further specified) generated positive results.Swab and sample type and dates and times of testing were not provided.The user reported that the patient isolated after the test results.No further information will be provided.Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.Negative results do not rule out sars-cov-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with covid-19.Due to the risk of a false negative result potentially leading to no or delayed treatment, this event shall be considered reportable.

Manufacturer Narrative

Additional information/corrected data: abbott diagnostics scarborough, inc.Was unable to determine, the exact root cause of the reported issue.However, it could possibly be related to the specific patient sample.

• Brand Name: BINAXNOW COVID-19 AG CARD
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 11066603
• MDR Text Key: 234968240
• Report Number: 1221359-2020-00476
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 127880
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1