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 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Reference mfr.Report: 1221359-2020-00467, 1221359-2020-00468, 1221359-2020-00469, 1221359-2020-00470, 1221359-2020-00471, 1221359-2020-00472, 1221359-2020-00473, 1221359-2020-00474.The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).Based on the evidence available, it indicates that this device lot is performing within label claims.Investigation is not yet complete.Upon completion, abbott diagnostics (b)(4), inc.Will provide a supplemental report.

Event Description

A customer reported nine false negative results with the binaxnow covid-19 ag test.This report represents nine of nine.The customer reported false negative results on a kitted swab with the binaxnow covid-19 ag test performed (b)(6) 2020.The nasal swab was used to swab both nostrils, as indicated per the product insert.Six drops of extraction reagent was added to the test well, the swab was inserted immediately into the test and rotated three times clockwise, and the test was closed.After fifteen (15) minutes, the test indicated negative results.Repeat testing was not performed.A specimen was collected immediately for confirmatory testing by pcr (not further specified).The results were positive (ct value not provided).The customer confirmed no death or serious injury based on the binaxnow covid-19 ag test results.The patient was symptomatic (not otherwise specified) for three days at the time of testing.No treatment was provided to the patient.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.

• 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
• Manufacturer (Section G): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alonna pitreau ; 10 southgate road; scarborough, ME 04074 ; 2077305750
• MDR Report Key: 11057584
• MDR Text Key: 240345222
• Report Number: 1221359-2020-00475
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721040810128566
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 128566
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2020
• 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: 70 YR