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 Non Reproducible Results (4029)

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

Event Type  malfunction  

Manufacturer Narrative

Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 126383 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 126383 and device part number 195-430h / lot 124978.Quality control release testing met specifications.The current overall incident rate for conflicting patient results (confirmed and unconfirmed results) for this specific lot based on the total quantity of devices manufactured for distribution 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.

Event Description

The customer reported conflicting results with the binaxnow covid-19 ag test.The customer reported a negative result on a nasal swab with the binaxnow covid-19 ag test at 15minutes.The results were reported to the patient.Then, just prior to the 30 minute mark, the test was re-red and there was a very faint positive line.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, and then, the swab was inserted.Repeat and confirmation testing were not performed.The customer confirmed there was no death or serious injury based on the binaxnow covid-19 ag test results.The customer reported a delay in patient treatment because notification of positive results was delayed.It was unknown if the patient was symptomatic at the time of testing.No patient information, treatment and outcome, was provided.The binaxnow covid-19 ag card pi states that in order to ensure proper test performance, it is important to read the result promptly at 15 minutes, and not before.Results should not be read after 30 minutes.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.Positive results indicate the presence of viral antigens.Inadequate or inappropriate sample collection, storage, and transport may yield false test results.Changing of gloves between handling of specimens suspected of covid-19 to prevent contamination.Unexplained conflicting results within the 15-30 minute result read time on a single test device shall be reported as a malfunction as it is unknown which result is correct.

• 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: 11066622
• MDR Text Key: 241473622
• Report Number: 1221359-2020-00479
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721031410126383
• 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
• Type of Report: Initial
• Report Date: 12/22/2020

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: 03/14/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 126383
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2020
• 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