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

The investigation is not yet complete.Upon completion, a supplemental report will be submitted to the fda.

Event Description

The customer reported a false negative on an immediately tested nasal kitted swab with binaxnow covid-19 ag card performed on (b)(6) 2020.The swab was used to collect samples from both nostrils, as indicated per product insert.6 drops of extraction reagent was added to the top hole of the test card.The customer thought (though he could not be sure) that the reagent was added before immediately inserting the swab.The swab was rotated 3 to 4 times clockwise.The test was read between 15 and twenty 20 minutes later.Confirmation testing by pcr performed on (b)(6) 2020 generated positive results (ct values not provided).The customer confirmed there was no death or serious injury based on binax now covid-19 ag result.The patient's treatment was not impacted or delayed based on the binax now covid-19 ag result.The patient was asymptomatic at the time of testing.The patient quarantined after receiving the positive covid-19 results.The customer stated it was the first time using the binaxnow covid-19 ag test.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 potential false negative result leading to no or delayed treatment, this event shall be considered reportable.

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 131710 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 131710 and device part number 195-430h / lot 129640a 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 131710 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

Correction to root cause: abbott diagnostics (b)(4) 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
• 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: 11091412
• MDR Text Key: 250774652
• Report Number: 1221359-2020-00456
• Device Sequence Number: 1
• Product Code: QKP
• 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: other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 131710
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2020
• 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: 19 YR
• Patient Weight: 48